40 Audit Associate jobs in Hyderabad
Audit Associate
Posted today
Job Viewed
Job Description
Dear All,
We are excited to announce a job opportunity at IRIS KPO Resourcing for the position of UK Audit Specialist. If you are a dynamic professional with strong coordination skills, a passion for auditing, and a keen interest and experience in UK Auditing, we would love to hear from you!
Job Location:
- Work From Home
Shift Timings:
- 2:00 PM to 11:00 PM
Key Responsibilities:
As an associate / senior Associate in the audit department, you will play a crucial role in delivering high-quality audit services to a diverse portfolio of clients within the United Kingdom. You will work closely with audit managers and partners of UK accountancy practice to plan and execute audit engagements, ensuring compliance with professional standards, regulations, and firm policies. The position requires strong technical and analytical skills, attention to detail, and the ability to work effectively within a team environment.
- Conduct audits of financial statements, operational processes, and compliance programs, ensuring accuracy, integrity, and adherence to applicable standards
- Review and audit the financial statements of UK-based enterprises to ensure adherence to legal accounting requirements (UK GAAP or IFRS)
- Participate in statutory audit work preparation with good understanding of all the phases (planning, execution and closure)
- Perform end to end audit function for entities across sectors, including small and medium companies
Experience & Qualifications:
- Participate in planning, organizing, and executing audit engagements for various clients, including conducting risk assessments, developing audit programs, and testing controls
- Perform substantive testing and analytical procedures to evaluate the accuracy and completeness of financial statements, ensuring compliance with auditing standards and relevant regulations
- Document audit procedures performed, findings, and conclusions in a clear and concise manner
- Identify control deficiencies and provide recommendations for improving clients' internal control systems and financial processes
- Collaborate with client personnel to gather necessary information and resolve audit-related queries or issues
- Strong application of data analytics in audit framework
- Work closely with audit team members, including associates and interns, providing guidance, reviewing their work, and offering constructive feedback
- Assist in the preparation of financial statements and related disclosures in accordance with applicable accounting standards (IFRS, UK GAAP, FRS)
- Stay up-to-date with changes in auditing standards, accounting regulations, and industry developments, and apply the knowledge to audit engagements
- Contribute to the development and enhancement of audit methodologies, tools, and templates
- Maintain effective communication with clients, building and maintaining professional relationships
Desired Competencies & Software expertise:
- 2-5 years of experience in end-to-end audit for UK clients
- Proficiency in audit software (CaseWare, Wolters Kluwer CCH Audit, MyWorkPapers, Inflo, Thomson Reuters etc.,)
- Experience in using accounting applications (IRIS, Sage, Xero etc.,)
- Knowledge in MS Office Suite
- In-depth knowledge of auditing standards, financial reporting frameworks (IFRS, FRS, UK GAAP) and relevant regulations (e.g., Companies Act)
Working knowledge of HAT and Mercia methodology
If you're passionate about project management and looking for an opportunity to grow within a collaborative environment, IRIS KPO Resourcing is the place for you!
Interested candidates can apply now!
Audit Associate
Posted today
Job Viewed
Job Description
Dear All,
We are excited to announce a job opportunity at IRIS KPO Resourcing for the position of UK Audit Specialist. If you are a dynamic professional with strong coordination skills, a passion for auditing, and a keen interest and experience in UK Auditing, we would love to hear from you!
Job Location:
- Work From Home
Shift Timings:
- 2:00 PM to 11:00 PM
Key Responsibilities:
As an associate / senior Associate in the audit department, you will play a crucial role in delivering high-quality audit services to a diverse portfolio of clients within the United Kingdom. You will work closely with audit managers and partners of UK accountancy practice to plan and execute audit engagements, ensuring compliance with professional standards, regulations, and firm policies. The position requires strong technical and analytical skills, attention to detail, and the ability to work effectively within a team environment.
- Conduct audits of financial statements, operational processes, and compliance programs, ensuring accuracy, integrity, and adherence to applicable standards
- Review and audit the financial statements of UK-based enterprises to ensure adherence to legal accounting requirements (UK GAAP or IFRS)
- Participate in statutory audit work preparation with good understanding of all the phases (planning, execution and closure)
- Perform end to end audit function for entities across sectors, including small and medium companies
Experience & Qualifications:
- Participate in planning, organizing, and executing audit engagements for various clients, including conducting risk assessments, developing audit programs, and testing controls
- Perform substantive testing and analytical procedures to evaluate the accuracy and completeness of financial statements, ensuring compliance with auditing standards and relevant regulations
- Document audit procedures performed, findings, and conclusions in a clear and concise manner
- Identify control deficiencies and provide recommendations for improving clients' internal control systems and financial processes
- Collaborate with client personnel to gather necessary information and resolve audit-related queries or issues
- Strong application of data analytics in audit framework
- Work closely with audit team members, including associates and interns, providing guidance, reviewing their work, and offering constructive feedback
- Assist in the preparation of financial statements and related disclosures in accordance with applicable accounting standards (IFRS, UK GAAP, FRS)
- Stay up-to-date with changes in auditing standards, accounting regulations, and industry developments, and apply the knowledge to audit engagements
- Contribute to the development and enhancement of audit methodologies, tools, and templates
- Maintain effective communication with clients, building and maintaining professional relationships
Desired Competencies & Software expertise:
- 2-5 years of experience in end-to-end audit for UK clients
- Proficiency in audit software (CaseWare, Wolters Kluwer CCH Audit, MyWorkPapers, Inflo, Thomson Reuters etc.,)
- Experience in using accounting applications (IRIS, Sage, Xero etc.,)
- Knowledge in MS Office Suite
- In-depth knowledge of auditing standards, financial reporting frameworks (IFRS, FRS, UK GAAP) and relevant regulations (e.g., Companies Act)
Working knowledge of HAT and Mercia methodology
If you're passionate about project management and looking for an opportunity to grow within a collaborative environment, IRIS KPO Resourcing is the place for you!
Interested candidates can apply now!
Audit Associate
Posted today
Job Viewed
Job Description
Dear All,
We are excited to announce a job opportunity at IRIS KPO Resourcing for the position of UK Audit Specialist. If you are a dynamic professional with strong coordination skills, a passion for auditing, and a keen interest and experience in UK Auditing, we would love to hear from you!
Job Location:
- Work From Home
Shift Timings:
- 2:00 PM to 11:00 PM
Key Responsibilities:
As an associate / senior Associate in the audit department, you will play a crucial role in delivering high-quality audit services to a diverse portfolio of clients within the United Kingdom. You will work closely with audit managers and partners of UK accountancy practice to plan and execute audit engagements, ensuring compliance with professional standards, regulations, and firm policies. The position requires strong technical and analytical skills, attention to detail, and the ability to work effectively within a team environment.
- Conduct audits of financial statements, operational processes, and compliance programs, ensuring accuracy, integrity, and adherence to applicable standards
- Review and audit the financial statements of UK-based enterprises to ensure adherence to legal accounting requirements (UK GAAP or IFRS)
- Participate in statutory audit work preparation with good understanding of all the phases (planning, execution and closure)
- Perform end to end audit function for entities across sectors, including small and medium companies
Experience & Qualifications:
- Participate in planning, organizing, and executing audit engagements for various clients, including conducting risk assessments, developing audit programs, and testing controls
- Perform substantive testing and analytical procedures to evaluate the accuracy and completeness of financial statements, ensuring compliance with auditing standards and relevant regulations
- Document audit procedures performed, findings, and conclusions in a clear and concise manner
- Identify control deficiencies and provide recommendations for improving clients' internal control systems and financial processes
- Collaborate with client personnel to gather necessary information and resolve audit-related queries or issues
- Strong application of data analytics in audit framework
- Work closely with audit team members, including associates and interns, providing guidance, reviewing their work, and offering constructive feedback
- Assist in the preparation of financial statements and related disclosures in accordance with applicable accounting standards (IFRS, UK GAAP, FRS)
- Stay up-to-date with changes in auditing standards, accounting regulations, and industry developments, and apply the knowledge to audit engagements
- Contribute to the development and enhancement of audit methodologies, tools, and templates
- Maintain effective communication with clients, building and maintaining professional relationships
Desired Competencies & Software expertise:
- 2-5 years of experience in end-to-end audit for UK clients
- Proficiency in audit software (CaseWare, Wolters Kluwer CCH Audit, MyWorkPapers, Inflo, Thomson Reuters etc.,)
- Experience in using accounting applications (IRIS, Sage, Xero etc.,)
- Knowledge in MS Office Suite
- In-depth knowledge of auditing standards, financial reporting frameworks (IFRS, FRS, UK GAAP) and relevant regulations (e.g., Companies Act)
Working knowledge of HAT and Mercia methodology
If you're passionate about project management and looking for an opportunity to grow within a collaborative environment, IRIS KPO Resourcing is the place for you!
Interested candidates can apply now!
Internal Audit-Risk Engineering Audit- Associate- Hyderabad
Posted today
Job Viewed
Job Description
What We Do
As the third line of defense, Internal Audit’s mission is to independently assess the firm’s internal control structure, including the firm’s governance processes and controls, and risk management and capital and anti-financial crime frameworks, raise awareness of control risk and monitor the implementation of management’s control measures. In doing so, internal Audit:
Goldman Sachs Internal Audit comprises individuals from diverse backgrounds including chartered accountants, developers, risk management professionals, cybersecurity professionals, and data scientists. We are organized into global teams comprising business and technology auditors to cover all the firm’s businesses and functions, including securities, investment banking, consumer and investment management, risk management, finance, cyber-security and technology risk, and engineering.
Who We Look For
Goldman Sachs Internal Auditors demonstrate strong risk and control mindsets, analytical, exercise professional skepticism and are able to challenge and discuss effectively with management on risks and control measures. We look for individuals who enjoy learning about audit, businesses and functions, have innovative and creative mindsets to adopt analytical techniques to enhance audit techniques, building relationships and are able to evolve and thrive in teamwork and in a fast-paced global environment.
Your Impact
As part of the third line of defense, you will be involved in independently assessing the firm’s overall control environment, and communicating the results to the firm’s local and global management the effectiveness of the firm’s controls that mitigate current and emerging risks, and monitoring the management’s implementation of control measures. In doing so, you are supporting the provision of independent, objective and timely assurance around the firm’s internal control structure, and supporting the Audit Committee, the Board of Directors and Risk Committee in fulfilling their oversight responsibilities.
Responsibilities
You will play a vital role in audit execution focusing on the review of Technology processes and analyzing the risks involved and assessing the design and operating effectiveness of the controls implemented to mitigate the risk. You will be responsible in documenting the assessments and testing conducted and discussing the results with the firms local and global management. In addition, you will also monitor and follow up with management on the resolution of the open audit findings.
Basic Qualifications
Preferred Qualifications
ABOUT GOLDMAN SACHS
At Goldman Sachs, we commit our people, capital and ideas to help our clients, shareholders and the communities we serve to grow. Founded in 1869, we are a leading global investment banking, securities and investment management firm. Headquartered in New York, we maintain offices around the world.
We believe who you are makes you better at what you do. We're committed to fostering and advancing diversity and inclusion in our own workplace and beyond by ensuring every individual within our firm has a number of opportunities to grow professionally and personally, from our training and development opportunities and firmwide networks to benefits, wellness and personal finance offerings and mindfulness programs. Learn more about our culture, benefits, and people at /careers.
We’re committed to finding reasonable accommodations for candidates with special needs or disabilities during our recruiting process.
Internal Audit-Hyderabad-Associate-Business Audit
Posted today
Job Viewed
Job Description
Internal Audit – Bengaluru – Associate – Enterprise Audit
The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations, financial institutions, governments, and individuals. Founded in 1869, the firm is headquartered in New York and maintains offices in all major financial centers around the world. We commit people, capital and ideas to help our clients, shareholders and the communities we serve to grow. Our people are our greatest asset – we say it often and with good reason. It is only with the determination and dedication of our people that we can serve our clients, generate long-term value for our shareholders and contribute to the broader public. We take pride in supporting each colleague both professionally and personally. From collaborative workspaces and ergonomic services to well-being and resilience offerings, we offer our people the flexibility and support they need to reach their goals in and outside the office
INTERNAL AUDIT
In Internal Audit, we ensure that Goldman Sachs maintains effective controls by assessing the reliability of financial reports, monitoring the firm’s compliance with laws and regulations, and advising management on developing smart control solutions. Our group has unique insight on the financial industry and its products and operations. We’re looking for detail-oriented team players who have an interest in financial markets and want to gain insight into the firm’s operations and control processes.
WHAT WE LOOK FOR
Goldman Sachs Internal Auditors demonstrate strong risk and control mindsets, analytical, exercise professional skepticism and are able to challenge and discuss effectively with management on risks and control measures. We look for individuals who enjoy learning about audit, businesses and functions, have innovative and creative mindsets to adopt analytical techniques to enhance audit techniques, building relationships and are able to evolve and thrive in teamwork and in a fast-paced global environment.
YOUR IMPACT
As the third line of defense, Internal Audit’s mission is to independently assess the firm’s internal control structure, including the firm’s governance processes and controls, and risk management and capital and anti-financial crime frameworks, raise awareness of control risk and monitor the implementation of management’s control measures. In doing so, internal Audit:
Goldman Sachs Internal Audit comprises individuals from diverse backgrounds including chartered accountants, developers, risk management professionals, cybersecurity professionals, and data scientists. We are organized into global teams comprising business and technology auditors to cover all the firm’s businesses and functions, including securities, investment banking, consumer and investment management, risk management, finance, cyber-security and technology risk, and engineering.
RESPONSIBILITIES
As an Associate, you will be responsible for execution of audit deliverables through effective time management, in accordance with the internal audit methodology of the department. You will assist the project manager in planning the scope of the audit, conduct walkthroughs and discussions with various teams to execute the audit scope and discuss results of the audit with the firms local and global management. You will play a vital role in execution of the audit scope, through succinct documentation and active engagement with various stakeholders focusing on analyzing the risks involved, assessing the design and operating effectiveness of the key controls implemented to mitigate the risk, in accordance with the internal audit methodology of the department. In addition, you will also monitor and follow up with management on the resolution of the open audit findings and maintain stakeholder relationship to monitor risk in their space. Job responsibilities also include assisting in the department’s continuous monitoring effort to cover operations incidents, market and regulatory events, business and technology updates. You are strongly encouraged to participate in department-wide initiatives aimed at continually improving IA's processes and supporting infrastructure.
Basic Qualifications
Internal Audit - C&T Engineering Audit - Associate - Hyderabad
Posted today
Job Viewed
Job Description
As the third line of defense, Internal Audit’s mission is to independently assess the firm’s internal control structure, including the firm’s governance processes and controls, and risk management and capital and anti-financial crime frameworks, raise awareness of control risk and monitor the implementation of management’s control measures. In doing so, internal Audit:
Goldman Sachs Internal Audit comprises individuals from diverse backgrounds including chartered accountants, developers, risk management professionals, cybersecurity professionals, and data scientists. We are organized into global teams comprising business and technology auditors to cover all the firm’s businesses and functions, including securities, investment banking, consumer and investment management, risk management, finance, cyber-security and technology risk, and engineering.
Who We Look For
Goldman Sachs Internal Auditors demonstrate strong risk and control mindsets, analytical, exercise professional skepticism and are able to challenge and discuss effectively with management on risks and control measures. We look for individuals who enjoy learning about audit, businesses and functions, have innovative and creative mindsets to adopt analytical techniques to enhance audit techniques, building relationships and are able to evolve and thrive in teamwork and in a fast-paced global environment.
Your Impact
As part of the third line of defense, you will be involved in independently assessing the firm’s overall control environment, and communicating the results to the firm’s local and global management the effectiveness of the firm’s controls that mitigate current and emerging risks, and monitoring the management’s implementation of control measures. In doing so, you are supporting the provision of independent, objective and timely assurance around the firm’s internal control structure, and supporting the Audit Committee, the Board of Directors and Risk Committee in fulfilling their oversight responsibilities.
Responsibilities
You will play a vital role in audit execution focusing on the review of Technology processes and analyzing the risks involved and assessing the design and operating effectiveness of the controls implemented to mitigate the risk. You will be responsible in documenting the assessments and testing conducted and discussing the results with the firms local and global management. In addition, you will also monitor and follow up with management on the resolution of the open audit findings.
Basic Qualifications
Preferred Qualifications
ABOUT GOLDMAN SACHS
At Goldman Sachs, we commit our people, capital and ideas to help our clients, shareholders and the communities we serve to grow. Founded in 1869, we are a leading global investment banking, securities and investment management firm. Headquartered in New York, we maintain offices around the world.
We believe who you are makes you better at what you do. We're committed to fostering and advancing diversity and inclusion in our own workplace and beyond by ensuring every individual within our firm has a number of opportunities to grow professionally and personally, from our training and development opportunities and firmwide networks to benefits, wellness and personal finance offerings and mindfulness programs. Learn more about our culture, benefits, and people at /careers.
We’re committed to finding reasonable accommodations for candidates with special needs or disabilities during our recruiting process.
Internal Audit-Hyderabad-Associate-Product Management
Posted today
Job Viewed
Job Description
Internal Audit (IA) examines, evaluates and performs an independent assessment of the firm's control environment and reports findings back to senior management and the firm's Audit Committee. As an independent function, IA provides objective assurance on the adequacy and effectiveness of the firm's internal control structure.
The IA Technology Strategy Office (TSO) spearheads the strategic vision for IA's technological advancement. We empower auditors through process reengineering, intelligent automation, and cutting-edge data analytics. Our team comprises passionate program managers, product managers, and business analysts who collaborate closely with designers, engineers, and data scientists to architect and deliver innovative technologies that transform the audit workflow.
JOB DESCRIPTION, PRODUCT OWNER – ASSOCIATE
As a Product Owner within the IA TSO, you will be a key driver in shaping the future of Internal Audit through technology. You will own the product lifecycle from conception to launch, working closely with stakeholders across IA and Technology to deliver solutions that directly impact the efficiency and effectiveness of the audit process.
Responsibilities:
QUALIFICATIONS
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Corporate Audit Senior Associate

Posted 12 days ago
Job Viewed
Job Description
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller, and longer. We discover, develop, manufacture, and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
**Role Description:**
The Corporate Audit Senior Associate will report to the Corporate Audit Senior Manager. The Audit Senior Associate will assist the Chief Audit Executives, Director, Senior Managers and Staff of Amgen Corporate Audit in providing independent, objective assurance and consulting services.
The Corporate Audit Senior Associate will support with International, functional and Healthcare compliance audits by analyzing data to identify higher risk transactions; perform sample selection for the audits and to test transactions to determine if the company's system of risk management, control and governance processes are adequate and functioning in a manner appropriate to a company of Amgen's size and market.
In addition, the Corporate Audit Senior Associate will support the team by further streamlining the audits and using automation; robotics and AI were possible and appropriate.
**Roles & Responsibilities:**
Effectively plans, coordinates, and conducts periodic audits of Amgen business processes in accordance with approved annual audit plans.
Demonstrates a high level of professionalism and the ability to manage multiple projects simultaneously
Successfully manages and cultivates key relationships to ensure that Corporate Audit's scope of work and the objectives of the organization are completed in a cost-effective and timely manner
Exercises excellent judgment and initiative in handling business issues of significance to Corporate Audit and the Company
Effectively researches the laws, codes, and regulations applicable to the healthcare compliance; finance; data privacy; ABAC risks and functional risks
Execute audits, including but not limited to analyzing data, performing sample selection and executing transactional testing.
Drafts work papers documenting work performed and written communications of audit results
Provides project management responsibility for accomplishments of audit timelines
Pro-actively suggest improvements to streamline the audit process by the use of automation; robotics and AI
Discharges responsibilities in a manner that is consistent with The Institute of Internal Auditors' Code of Ethics, International Standards for the Professional Practice of Internal Auditing and Statement of Responsibilities, as well as the Association of Healthcare Compliance Internal Auditors Seven Component Framework
Travel up to 15% per year
**Must-Have Skills:**
Knowledge and understanding of internal control framework and International Compliance and Finance risks.
Audit experience (preferably with big 4 company)
Pharmaceutical / biotechnology industry experience
Excellent business acumen (e.g., knowledge of business drivers, finding solutions, and knowledge of accounting, finance, and other business areas)
**Good-to-Have Skills:**
Proficient in Microsoft Word, Excel, Power Point, Visio, as well as AuditBoard, Tableau, Alteryx, Smartsheets
Big 4 and Fortune 500 internal audit experience
Initiative-taker with excellent project management skills
**Professional Certifications** **_(please mention if the certification is preferred or mandatory for the role):_**
Relevant auditing or compliance professional certifications: Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Chartered Accountant, Certified Compliance and Ethics Professional (CCEP), and/or Certified Fraud Examiner (CFE)
Advanced certification (i.e., MBA)
**Soft Skills:**
Analytical, interpersonal, team building, leadership, and conflict resolution skills
Effective communication skills (both verbal and written), including the ability to interact with Amgen senior management effectively and confidentially.
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Collaborative, with a focus on achieving team goals
Strong presentation and public speaking skills.
**Basic Qualifications:**
Master's degree, OR
Bachelor's degree and 3 years of Audit experience, OR
Associate's degree and 6 years of Audit experience.
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
R&D Audit - Sr Associate

Posted 12 days ago
Job Viewed
Job Description
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Quality Specialist**
**Live**
**What you will do**
Let's do this. Let's change the world. In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does.
+ Data entry into Amgen's Quality System of approved audit responses
+ Audit resourcing/planning
+ Quarterly Investigator Site audit planning including identifying audit resources through risk assessment of audit targets on a regular basis
+ Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits
+ Updating Audit tracking and accountability tools and distributing/communicating allocations to the audit teams
+ Compiling Audit reporting metrics and communication
+ Manage Audit documentation and filing
+ Supporting outsourced audits by:
+ Supporting outsourced audit resourcing/planning for Audits
+ Provide necessary tools, reports/documentation, and access to systems for outsourced Audits
+ Review initial draft audit reports, audit responses and debrief slides.
+ Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings
+ QC Data entry into AMS of audit findings
+ Confirming data entry into RDCS of approved audit responses
+ Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports
+ Provide guidance and resolve queries from external Audit vendors
+ Weekly Meeting with external audit vendor to review tasks and status of audits
+ Communicate noncompliance to Manager
+ Administrative Support (includes maintaining & updating distribution lists and templates)
+ Data entry/QC in to the Audit Management System (Trackwise) of audit findings
+ Administrative support for audit resourcing/planning
+ Manages Audit documentation and filing
+ Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable
+ Follow up with CAPA Owners for completion dates and objective evidence
+ Review and Append Objective evidence in Amgen's Quality System and close record
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has a 'can do' approach with these qualifications.
Basic Qualifications:
+ Master's degree in Life sciences or related field
Preferred Qualifications:
+ Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
+ Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities
+ Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
+ Quality Assurance Qualification/Certification (preferred)
R&D Audit - Sr Associate

Posted 12 days ago
Job Viewed
Job Description
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Quality Specialist**
**Live**
**What you will do**
Let's do this. Let's change the world. In this vital role you will Support the R&D quality Audit and help to build quality into everything Amgen does.
+ Data entry into Amgen's Quality System of approved audit responses
+ Audit resourcing/planning
+ Quarterly Investigator Site audit planning including identifying audit resources through risk assessment of audit targets on a regular basis
+ Yearly planning of other audit types including internal process/Service Provider and Affiliate Audits
+ Updating Audit tracking and accountability tools and distributing/communicating allocations to the audit teams
+ Compiling Audit reporting metrics and communication
+ Manage Audit documentation and filing
+ Supporting outsourced audits by:
+ Supporting outsourced audit resourcing/planning for Audits
+ Provide necessary tools, reports/documentation, and access to systems for outsourced Audits
+ Review initial draft audit reports, audit responses and debrief slides.
+ Schedule and facilitate Quality Lead (pre-audit meetings) and audit debrief meetings
+ QC Data entry into AMS of audit findings
+ Confirming data entry into RDCS of approved audit responses
+ Oversee timelines met for issuance of Initial audit reports; review of audit responses and issuing Final Audit Reports
+ Provide guidance and resolve queries from external Audit vendors
+ Weekly Meeting with external audit vendor to review tasks and status of audits
+ Communicate noncompliance to Manager
+ Administrative Support (includes maintaining & updating distribution lists and templates)
+ Data entry/QC in to the Audit Management System (Trackwise) of audit findings
+ Administrative support for audit resourcing/planning
+ Manages Audit documentation and filing
+ Ensures that the Audit Archive is updated with Final audit reports and closure memos and Plans/Agendas where applicable
+ Follow up with CAPA Owners for completion dates and objective evidence
+ Review and Append Objective evidence in Amgen's Quality System and close record
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek has a 'can do' approach with these qualifications.
Basic Qualifications:
+ Master's degree in Life sciences or related field
Preferred Qualifications:
+ Minimum of 3-5 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
+ Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities
+ Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
+ Quality Assurance Qualification/Certification (preferred)