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Showing 30 Quality Assurance Manager jobs in Delhi

Quality Assurance Manager - Manufacturing

110001 Delhi, Delhi ₹1300000 Annually WhatJobs Direct

Posted 2 days ago

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full-time
Our client is a leading manufacturing firm seeking a highly experienced and detail-oriented Quality Assurance Manager to oversee and enhance their quality management systems. This crucial role involves ensuring that all manufactured products meet stringent quality standards, regulatory requirements, and customer expectations. The ideal candidate will possess a deep understanding of quality control methodologies, statistical process control (SPC), and a proven ability to lead and mentor quality assurance teams.

Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with relevant standards (e.g., ISO 9001, industry-specific certifications).
  • Establish and monitor key quality metrics and performance indicators, implementing corrective and preventive actions (CAPA) as needed.
  • Lead and manage the Quality Assurance team, providing guidance, training, and performance evaluations.
  • Oversee all aspects of product quality, from raw material inspection to finished goods testing and release.
  • Conduct internal audits and support external audits by regulatory bodies and customers.
  • Collaborate with production, engineering, and R&D teams to identify and resolve quality issues promptly.
  • Implement and manage statistical process control (SPC) techniques to monitor and control manufacturing processes.
  • Develop and update quality control procedures, work instructions, and documentation.
  • Investigate customer complaints related to product quality and implement effective solutions.
  • Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.
  • Manage supplier quality assurance programs, including audits and performance monitoring.
  • Ensure compliance with all applicable health, safety, and environmental regulations related to quality.
  • Prepare regular reports on quality performance for senior management.
  • Promote a strong quality culture throughout the organization.
  • Stay current with evolving quality standards and best practices in the manufacturing industry.

The ideal candidate will hold a Bachelor's degree in Engineering (Mechanical, Industrial, or related field) or a relevant scientific discipline, with a minimum of 6 years of experience in Quality Assurance within a manufacturing environment. Experience with ISO 9001 certification and implementation is essential. Strong knowledge of quality control tools, statistical analysis, SPC, and problem-solving methodologies (e.g., Six Sigma, Lean Manufacturing) is required. Excellent leadership, communication, and interpersonal skills are critical for managing the QA team and collaborating effectively with other departments. Proficiency in quality management software and standard office applications is expected. This role is based in **Delhi, Delhi, IN** and operates on a hybrid model, requiring a balance of in-office presence for team leadership and process oversight, with flexibility for remote work.

We are seeking a dedicated and proactive leader committed to upholding the highest quality standards and driving manufacturing excellence. If you are passionate about quality and ready to make a significant impact in a leading manufacturing organization, we encourage you to apply.
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Senior Quality Assurance Manager

Delhi, Delhi PharmaSecure

Posted 2 days ago

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Job Description

Job Title: Sr. Manager - Quality

Location: Delhi, India

Status: Full-Time


About PharmaSecure

PharmaSecure is a global track-and-trace, product authentication, and consumer engagement company that has helped protect over 8 billion packages through its technology-enabled solutions on hundreds of manufacturing lines. The codes printed are generated using its patented, encryption-based algorithm that provides unmatched security.


It has a proven track record of implementing minimal changes to the existing manufacturing process and negligible downtime of manufacturing lines by providing a solution that seamlessly integrates into the existing operations.


It’s proven serialization capabilities have enabled large pharmaceutical companies to meet different traceability requirements, as it ensures that pharma manufacturers exporting to various countries maintain regulatory compliances.


Other than being experts in global track-and-trace, product authentication, and consumer engagement, PharmaSecure is also an OEM for efficient machines to provide a full suite of software and hardware solutions under one umbrella.


Overview of Role

The Senior Manager – Quality will be responsible for ensuring the quality and compliance of software applications, IT systems, and related processes in alignment with regulatory requirements in the pharmaceutical sector. The role involves testing, validating, and verifying that all systems meet industry standards, including GxP compliance, 21 CFR Part 11, and other applicable regulations. The candidate should have a keen eye for detail, a strong understanding of pharma industry guidelines, and experience in software testing and validation.


Principal Responsibilities and Accountabilities

  • Software Testing & Validation :
  • Design and/or review manual and automated test cases for IT systems.
  • Perform validation of pharma-related IT systems as per GMP guidelines.
  • Ensure compliance with 21 CFR Part 11 and other global pharmaceutical regulatory standards.
  • Ensure testing for all IT systems and applications is in-line with PhrmaSecure QMS.
  • Supervise Manage defect tracking and resolution with development teams.
  • Documentation :
  • Prepare/Review validation documentation, including Test Plans, Test Scripts, Validation Protocols, and Reports (IQ/OQ/PQ).
  • Maintain records of test results, issues identified, and corrective actions.
  • Assist in maintaining Standard Operating Procedures (SOPs) and ensuring they are followed during testing and validation activities.
  • Regulatory Compliance :
  • Ensure IT systems and processes adhere to industry-specific regulatory standards (GxP, GMP, GAMP 5, and Data Integrity requirements) and maintain continuous compliance.
  • Oversee both QA and Regulatory Affairs responsibilities to ensure alignment with evolving pharmaceutical and IT regulations.
  • Act as the primary liaison for internal and external audits, ensuring all IT systems meet regulatory and compliance standards.
  • Stay updated on regulatory changes affecting pharma IT systems and incorporate new requirements into QA and regulatory processes.
  • Risk Management :
  • Conduct risk assessments and develop mitigation strategies for IT systems.
  • Identify potential risks and issues early in the development lifecycle to prevent system failures post-deployment.
  • Collaboration & Support :
  • Work closely with cross-functional teams (IT, Development, Manufacturing, Regulatory, etc.) to ensure a smooth transition of systems from development to production.
  • Provide training and support to end-users for validated IT systems.
  • Assist with internal and external audits, ensuring IT QA compliance is maintained.

Competencies

  • Fluency in English.
  • Excellent written and verbal communication skills.
  • Excellent teamwork skills.
  • Excellent attention to detail, quality and control.
  • Proven ability to influence cross-functional teams without formal authority.



Required experience and knowledge

  • 10 plus years of experience in IT Quality Assurance, preferably in the pharmaceutical or life sciences sector.
  • Proven track record of validating GxP-compliant systems in a regulated environment.
  • Familiarity with GAMP 5, 21 CFR Part 11, Data Integrity, and other relevant pharma regulations.
  • Bachelor's or Master's degree in Information Technology, Computer Science, or a related field.
  • Certifications like ISTQB, Six Sigma, or relevant QA certifications are a plus.
  • Hands-on experience with test management tools (JIRA, HP ALM, etc.).
  • Knowledge of SQL and scripting for database and application testing.
  • Familiarity with automated testing tools (Selenium, QTP, etc.).
  • Experience with ISO standards 9001 and 27001.
  • Knowledge of Pharma machines validation will be an added advantage.


Compensation

Candidates that meet all the above requirements will be considered for competitive compensation commensurate with their experience.

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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1800000 Annually WhatJobs Direct

Posted today

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Job Description

full-time
Our client, a prominent pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their QA operations. This is a critical, fully remote position, offering the opportunity to shape quality standards and compliance initiatives from anywhere. You will be responsible for establishing, implementing, and maintaining the company's Quality Management System (QMS) in accordance with global regulatory requirements, including GMP, ICH guidelines, and relevant health authority regulations. Your role will involve overseeing all aspects of QA, including batch record review, deviation management, CAPA implementation, change control, internal and external audits, and validation activities. You will play a pivotal role in ensuring product quality and patient safety throughout the drug development and manufacturing lifecycle. The ideal candidate possesses a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality control principles. Strong leadership skills, exceptional analytical and problem-solving abilities, and excellent communication and interpersonal skills are essential for effectively managing QA teams and collaborating with cross-functional departments such as R&D, Manufacturing, and Regulatory Affairs. As a remote leader, you must be highly organized, self-motivated, and adept at utilizing virtual collaboration tools to maintain effective communication and workflow with teams potentially working near **Delhi, Delhi, IN** and globally. You will also be responsible for driving continuous improvement initiatives within the QA function, mentoring QA personnel, and ensuring a culture of quality excellence throughout the organization. This position demands a proactive and detail-oriented professional committed to upholding the highest standards of pharmaceutical quality.

Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulations.
  • Oversee and manage all QA activities, including batch record review, release, deviation investigations, CAPA, and change control.
  • Lead internal audits and host regulatory agency inspections (e.g., FDA, EMA) and customer audits.
  • Ensure compliance with Good Manufacturing Practices (GMP) and other relevant industry standards.
  • Develop and execute validation master plans and protocols for equipment, processes, and systems.
  • Review and approve product quality related documentation, ensuring accuracy and completeness.
  • Manage and mentor a team of Quality Assurance professionals, fostering their development and performance.
  • Collaborate with R&D, Manufacturing, and Regulatory Affairs to ensure quality is built into products and processes.
  • Drive continuous improvement initiatives within the QA function to enhance efficiency and compliance.
  • Stay updated on evolving regulatory requirements and industry best practices.
Qualifications:
  • Master's degree or Ph.D. in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life science field.
  • Minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
  • Extensive knowledge of GMP, ICH guidelines, and global regulatory requirements.
  • Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
  • Strong leadership, team management, and interpersonal skills.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Exceptional written and verbal communication skills.
  • Ability to work independently and effectively in a fully remote environment.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹130000 Annually WhatJobs Direct

Posted 2 days ago

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Job Description

full-time
Our client is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to oversee and enhance quality systems at their facility in **Delhi, Delhi, IN**. This critical role ensures compliance with all relevant regulatory standards, including GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and GDP (Good Distribution Practices). You will be responsible for developing, implementing, and maintaining robust quality assurance programs, leading internal and external audits, and managing deviations and corrective/preventive actions (CAPAs). The ideal candidate will possess an in-depth understanding of the pharmaceutical manufacturing process, quality control methodologies, and regulatory requirements. You will lead and mentor a team of QA professionals, fostering a culture of quality excellence and continuous improvement. Key responsibilities include reviewing and approving batch records, validation protocols, and change controls; investigating quality incidents; and ensuring the integrity and reliability of all manufactured products. Strong leadership, analytical, and problem-solving skills are essential. The ability to communicate effectively with regulatory agencies, senior management, and cross-functional teams is paramount. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field, along with a minimum of 8 years of progressive experience in pharmaceutical quality assurance, is required. Experience in managing QA teams and conducting regulatory inspections is highly desirable. Familiarity with Quality Management Systems (QMS) and relevant software applications is also expected. This is an exceptional opportunity to take on a leadership role in ensuring the highest standards of quality and compliance within the pharmaceutical industry, contributing significantly to patient safety and product efficacy.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1800000 Annually WhatJobs

Posted 4 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly qualified Senior Pharmaceutical Quality Assurance Manager to lead their quality operations. This is a crucial, fully remote position, allowing you to oversee quality systems and ensure compliance from anywhere within India. The ideal candidate will possess extensive experience in pharmaceutical quality assurance, GMP (Good Manufacturing Practices), regulatory affairs, and quality control. You will be responsible for developing, implementing, and maintaining robust quality management systems to ensure product safety, efficacy, and regulatory compliance across all stages of drug development and manufacturing. This role demands a strategic thinker with exceptional leadership and analytical skills.

Key Responsibilities:
  • Develop, implement, and manage the company's Quality Management System (QMS) in compliance with global pharmaceutical regulations (e.g., FDA, EMA, WHO).
  • Oversee and ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
  • Lead and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement.
  • Conduct internal audits and support external regulatory inspections and audits from health authorities.
  • Review and approve batch records, validation protocols, and reports.
  • Manage deviations, investigations (CAPA), change controls, and risk assessments.
  • Ensure that all pharmaceutical products meet established quality standards and specifications.
  • Collaborate with R&D, Manufacturing, Regulatory Affairs, and other departments to resolve quality issues and drive product quality improvements.
  • Stay updated on evolving regulatory requirements and industry best practices.
  • Develop and deliver quality training programs to relevant personnel.
  • Manage vendor qualification and ongoing supplier quality agreements.
  • Prepare and present quality metrics and reports to senior management.

Qualifications:
  • Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 10-15 years of progressive experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
  • Deep understanding of pharmaceutical manufacturing processes, quality control, and regulatory compliance.
  • Proven experience in managing QMS, conducting audits, and successfully navigating regulatory inspections.
  • Strong knowledge of GMP, ICH guidelines, and other relevant international regulatory standards.
  • Excellent leadership, team management, and interpersonal skills.
  • Exceptional analytical, problem-solving, and decision-making abilities.
  • Superior written and verbal communication skills, with the ability to present complex information clearly.
  • Proficiency in using quality management software and tools.
  • Ability to work independently and effectively manage multiple priorities in a remote setting.
  • Commitment to upholding the highest ethical and quality standards.

This is a senior leadership opportunity within a highly respected pharmaceutical organization, offering significant impact and career advancement in a fully remote capacity. If you are a dedicated Quality Assurance professional ready to lead and innovate, we encourage you to apply.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1300000 Annually WhatJobs

Posted 9 days ago

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Job Description

full-time
Our client, a reputable pharmaceutical company renowned for its commitment to quality and innovation, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to join their operations in Delhi . This pivotal role is responsible for overseeing and enhancing the company's Quality Management System (QMS), ensuring compliance with national and international regulatory standards (e.g., GMP, FDA, WHO). The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, a meticulous attention to detail, and a strong leadership capability to guide the QA team. This position requires on-site presence to effectively manage quality operations and collaborate with manufacturing and regulatory affairs.

Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) to ensure compliance with all relevant pharmaceutical regulations and industry best practices.
  • Oversee all QA activities, including batch record review and release, deviation management, CAPA implementation, change control, and complaint handling.
  • Conduct regular internal audits and participate in external audits (regulatory inspections and client audits).
  • Ensure all manufacturing processes adhere to Good Manufacturing Practices (GMP).
  • Manage and mentor the Quality Assurance team, providing training and development opportunities.
  • Review and approve validation protocols and reports for equipment, processes, and analytical methods.
  • Collaborate with the Quality Control (QC) department to ensure timely and accurate testing of raw materials, intermediates, and finished products.
  • Work closely with Production, R&D, and Regulatory Affairs to resolve quality issues and implement corrective actions.
  • Stay updated on the latest regulatory requirements and industry trends in pharmaceutical quality assurance.
  • Prepare and present quality metrics and reports to senior management.
  • Lead continuous improvement initiatives to enhance product quality and manufacturing efficiency.
  • Ensure proper documentation control and record-keeping practices are maintained.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
  • A minimum of 8 years of experience in Quality Assurance within the pharmaceutical industry.
  • In-depth knowledge of GMP regulations, ICH guidelines, and other relevant pharmaceutical quality standards.
  • Proven experience in managing QMS, batch record review, deviations, CAPAs, and change control.
  • Strong leadership and team management skills.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Exceptional attention to detail and commitment to accuracy.
  • Strong written and verbal communication skills, with the ability to effectively interact with regulatory agencies and internal stakeholders.
  • Experience with pharmaceutical manufacturing processes and quality control testing.
  • Must be able to work on-site in Delhi .
This role offers a competitive salary and benefits package, along with the opportunity to contribute significantly to the quality and compliance of life-saving pharmaceutical products. Join a respected organization dedicated to excellence in healthcare.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹140000 Annually WhatJobs

Posted 11 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to oversee and maintain the highest standards of quality in drug manufacturing and development. This role is pivotal in ensuring compliance with global regulatory requirements, including GMP, FDA, and other relevant health authorities. You will be responsible for developing, implementing, and managing the company's quality management system (QMS), ensuring that all products meet stringent quality and safety standards before reaching patients.

Key responsibilities include conducting internal and external audits, managing deviations and CAPAs (Corrective and Preventive Actions), reviewing and approving batch records, and participating in regulatory inspections. You will lead and mentor a team of QA professionals, fostering a culture of quality and continuous improvement throughout the organization. The ideal candidate will possess a strong understanding of pharmaceutical manufacturing processes, analytical testing, validation, and regulatory affairs. Excellent communication, leadership, and problem-solving skills are essential. You will work closely with R&D, production, regulatory affairs, and other departments to ensure seamless quality oversight. This role requires meticulous attention to detail, strong documentation skills, and the ability to make critical decisions under pressure. The opportunity to contribute to the development and release of life-saving medications makes this a highly rewarding position. This hybrid role requires a balance of on-site presence for critical operations and remote flexibility for strategic planning and documentation review.

Location: Delhi, Delhi, IN .

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • 8+ years of experience in pharmaceutical quality assurance or quality control.
  • In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
  • Proven experience in managing QMS, audits, deviations, and CAPA systems.
  • Experience in leading and developing a QA team.
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent written and verbal communication skills.
  • Familiarity with pharmaceutical manufacturing processes and validation principles.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1200000 Annually WhatJobs

Posted 16 days ago

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Job Description

full-time
Our client is seeking an experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to lead their quality systems from a fully remote capacity. This critical role ensures that all pharmaceutical products manufactured and distributed meet the highest standards of safety, efficacy, and regulatory compliance. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, overseeing audits, managing documentation, and driving continuous improvement in quality processes. The ideal candidate will possess a deep understanding of GxP regulations, a strong background in pharmaceutical quality assurance, and exceptional leadership and communication skills, enabling effective remote management.

Key Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulatory standards (e.g., FDA, EMA, WHO).
  • Oversee and manage all QA activities, including batch record review, deviation management, CAPA (Corrective and Preventive Actions), and change control.
  • Conduct internal and external audits of manufacturing sites, contract manufacturers, and suppliers to ensure compliance.
  • Prepare for and host regulatory inspections, acting as a primary point of contact.
  • Review and approve validation protocols and reports for manufacturing processes, equipment, and analytical methods.
  • Develop and deliver training programs on quality assurance principles and regulatory requirements.
  • Manage product quality complaints and ensure timely investigation and resolution.
  • Analyze quality data to identify trends, root causes of issues, and opportunities for improvement.
  • Collaborate closely with R&D, manufacturing, regulatory affairs, and other departments to ensure quality is integrated throughout the product lifecycle.
  • Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
  • Lead cross-functional teams to address quality-related challenges and implement corrective actions.
  • Maintain all quality-related documentation, ensuring accuracy, completeness, and accessibility.
  • Develop and manage departmental budgets and resources effectively for a remote team.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life sciences field.
  • Minimum of 8 years of progressive experience in pharmaceutical Quality Assurance, with at least 3 years in a managerial role.
  • In-depth knowledge of cGMP, ICH guidelines, and other relevant global regulatory requirements.
  • Proven experience in managing QMS, conducting audits, and leading regulatory inspections.
  • Strong understanding of pharmaceutical manufacturing processes, validation, and analytical testing.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional leadership, communication, and interpersonal skills, with the ability to lead and motivate a remote team effectively.
  • Proficiency in quality management software and tools.
  • Ability to work independently, manage priorities, and meet strict deadlines in a remote setting.
  • Experience with biologics or sterile products is a plus.
This is a key remote leadership position within our client's organization, offering the chance to significantly impact product quality and patient safety across the globe, based from Delhi, Delhi, IN (remote focus).
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1800000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Manager to oversee and enhance the quality management systems across all stages of drug development and manufacturing. This critical role demands a deep understanding of regulatory requirements and a commitment to ensuring product safety, efficacy, and compliance. You will lead a team of QA professionals, driving continuous improvement initiatives and upholding the highest standards of pharmaceutical quality.

Responsibilities:
  • Develop, implement, and maintain robust Quality Assurance (QA) systems and procedures in compliance with cGMP, ICH, FDA, and other relevant regulatory guidelines.
  • Oversee all QA activities, including batch record review, deviation investigations, CAPA management, change control, and internal/external audits.
  • Lead and mentor a team of QA professionals, providing guidance, training, and performance management.
  • Ensure that all pharmaceutical products meet established quality standards and regulatory requirements prior to release.
  • Manage and conduct internal and external audits, including vendor qualification and audits of contract manufacturing organizations (CMOs).
  • Review and approve validation protocols and reports for equipment, processes, and analytical methods.
  • Prepare and host regulatory inspections and audits by health authorities.
  • Identify potential quality risks and implement proactive measures to mitigate them.
  • Contribute to the development and execution of quality strategies and initiatives.
  • Stay abreast of evolving regulatory landscapes and industry best practices to ensure ongoing compliance.

Qualifications:
  • Master's or Ph.D. in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance/Quality Control.
  • Extensive knowledge of cGMP regulations, ICH guidelines, and global pharmaceutical regulatory requirements.
  • Proven experience in leading QA teams and managing QA operations in a pharmaceutical manufacturing environment.
  • Demonstrated experience with regulatory inspections and successful audit outcomes.
  • Strong understanding of pharmaceutical manufacturing processes, product development, and analytical testing.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional communication, interpersonal, and leadership skills.
  • Ability to effectively manage multiple priorities and meet stringent deadlines.
  • Experience with quality risk management principles and tools.

This on-site role in Delhi, Delhi, IN presents a significant opportunity to shape the quality standards of a reputable pharmaceutical organization and contribute to the development of life-saving medicines.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹110000 Annually WhatJobs

Posted 20 days ago

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Job Description

full-time
Our client, a globally recognized pharmaceutical company committed to improving health outcomes, is looking for a highly experienced Senior Pharmaceutical Quality Assurance Manager to join their operations in **Delhi, Delhi**. This role offers a hybrid work model, allowing for a balanced approach to in-office collaboration and remote work flexibility.

The Senior QA Manager will be responsible for overseeing and directing all Quality Assurance activities within the assigned manufacturing and/or R&D facilities, ensuring compliance with cGMP, FDA, EMA, and other relevant regulatory requirements. This includes developing, implementing, and maintaining robust quality management systems, policies, and procedures. You will lead a team of QA professionals, providing guidance, training, and performance management to ensure high standards of quality are consistently met. Key responsibilities involve managing the deviation and CAPA (Corrective and Preventive Actions) systems, conducting internal and external audits, and leading regulatory inspections. You will play a critical role in product lifecycle management, ensuring quality is embedded from development through to commercialization. This includes reviewing and approving batch records, validation protocols and reports, and change controls. The Senior QA Manager will also be instrumental in risk assessment and mitigation strategies, identifying potential quality issues and implementing proactive solutions. Strong collaboration with Manufacturing, R&D, Regulatory Affairs, and other departments is essential to foster a culture of quality throughout the organization. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory landscapes, and quality control methodologies. Excellent leadership, communication, and problem-solving skills are paramount for success in this demanding role.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related life science field.
  • Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
  • Extensive knowledge of cGMP regulations, ICH guidelines, and pharmaceutical quality systems.
  • Proven experience in managing deviations, CAPAs, change controls, and audits.
  • Demonstrated leadership skills with experience managing a team of QA professionals.
  • Excellent understanding of pharmaceutical manufacturing processes and analytical testing.
  • Strong analytical, problem-solving, and decision-making abilities.
  • Exceptional written and verbal communication skills, with the ability to effectively interact with regulatory agencies and senior management.
  • Experience with regulatory submissions and inspections is highly desirable.
This is a significant opportunity to contribute to the quality and integrity of life-saving medicines at a leading pharmaceutical organization in **Delhi, Delhi**.
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