37 Quality Assurance Manager jobs in Bhubaneswar
Pharmaceutical Quality Assurance Manager
Posted 12 days ago
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Job Description
The ideal candidate will possess a deep understanding of the pharmaceutical industry, regulatory requirements (e.g., FDA, EMA, CDSCO), and quality assurance principles. Strong leadership, analytical, and problem-solving skills are essential. Responsibilities include reviewing batch records, validating processes and equipment, managing change control, handling customer complaints, and preparing for regulatory inspections. You will also be involved in supplier qualification, risk assessments, and continuous improvement initiatives. This role requires excellent communication skills to effectively liaise with cross-functional teams, regulatory bodies, and senior management. The ability to interpret complex regulatory documents and translate them into actionable quality procedures is paramount. This is a significant opportunity to contribute to the quality and safety of pharmaceutical products within a growing organization.
Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS).
- Ensure compliance with GMP, ISO, and other relevant regulatory standards.
- Lead and mentor the Quality Assurance team.
- Conduct internal and external audits of manufacturing facilities and suppliers.
- Manage deviations, investigations, and Corrective and Preventive Actions (CAPA).
- Review and approve batch records, specifications, and validation protocols.
- Oversee change control management processes.
- Prepare for and participate in regulatory inspections and audits.
- Manage product quality complaints and investigations.
- Drive continuous improvement initiatives within the quality department.
- Master's or Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field.
- Minimum 7-10 years of experience in Pharmaceutical Quality Assurance.
- Proven experience in implementing and managing QMS.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulations.
- Experience with regulatory inspections (e.g., FDA, EMA, CDSCO).
- Strong leadership, analytical, and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects and prioritize effectively in a hybrid work environment.
- Proficiency with quality management software and tools.
- Detail-oriented with a strong commitment to quality and compliance.
Remote Quality Assurance Manager
Posted 13 days ago
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Job Description
Responsibilities:
- Develop and implement comprehensive quality assurance strategies and procedures.
- Establish and manage quality control processes throughout the product lifecycle.
- Conduct internal audits and assessments to ensure compliance with quality standards and regulations.
- Analyze quality data, identify trends, and implement corrective and preventive actions.
- Lead and mentor a remote team of quality assurance professionals.
- Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.
- Oversee the testing and validation of products and services.
- Develop and maintain quality documentation, including SOPs and test protocols.
- Manage customer feedback related to product quality and implement necessary improvements.
- Promote a strong quality culture throughout the organization.
- Bachelor's degree in Engineering, Science, Business Administration, or a related field.
- Minimum of 7 years of experience in Quality Assurance or Quality Management roles.
- Proven experience in developing and implementing Quality Management Systems (QMS), such as ISO 9001.
- Strong knowledge of quality control tools and methodologies (e.g., Six Sigma, Lean Manufacturing).
- Experience in leading and managing remote QA teams.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong communication, interpersonal, and leadership abilities.
- Proficiency with quality management software and data analysis tools.
Pharmaceutical Quality Assurance Manager
Posted 15 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain a robust Quality Management System (QMS) in line with Good Manufacturing Practices (GMP), ICH guidelines, and other relevant regulatory requirements for pharmaceutical operations in Bhubaneswar, Odisha, IN .
- Oversee all quality assurance activities, including batch record review, product release, deviation management, change control, and CAPA (Corrective and Preventive Actions).
- Conduct internal audits and host regulatory inspections (e.g., FDA, EMA, local authorities), ensuring successful outcomes.
- Manage and mentor the Quality Assurance team, providing training and professional development opportunities.
- Ensure that all manufacturing processes, equipment, and facilities comply with current Good Manufacturing Practices (cGMP).
- Review and approve validation protocols and reports for manufacturing processes, analytical methods, and equipment.
- Monitor and analyze quality data, identify trends, and implement continuous improvement initiatives to enhance product quality and process efficiency.
- Manage product complaints and recalls, conducting thorough investigations and implementing necessary corrective actions.
- Liaise with regulatory bodies, suppliers, and external partners on quality-related matters.
- Champion a quality-focused culture throughout the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7-10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of GMP, GDP, ICH guidelines, and other relevant pharmaceutical regulations.
- Proven experience in managing regulatory inspections and audits.
- Strong understanding of pharmaceutical manufacturing, analytical testing, and validation principles.
- Excellent leadership, team management, and interpersonal skills.
- Proficiency in quality management software and tools.
- Exceptional analytical, problem-solving, and decision-making abilities.
- Strong documentation and report-writing skills.
- Detail-oriented with a commitment to accuracy and compliance.
Pharmaceutical Quality Assurance Manager
Posted 15 days ago
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Job Description
Senior Pharmaceutical Quality Assurance Manager
Posted 1 day ago
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Job Description
Key Responsibilities:
- Develop and implement pharmaceutical quality assurance systems.
- Ensure compliance with GMP, GLP, and other relevant regulations.
- Manage SOPs, change control, deviation management, and CAPA processes.
- Conduct internal audits and host regulatory inspections.
- Oversee batch record review and product release.
- Manage supplier quality assurance programs.
- Lead and mentor the QA team.
- Investigate quality incidents and implement corrective actions.
- Contribute to continuous improvement initiatives in quality management.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, or Life Sciences.
- 7-10 years of experience in pharmaceutical QA.
- In-depth knowledge of GMP and regulatory requirements.
- Experience with audits and inspections.
- Strong leadership and team management skills.
- Excellent analytical and problem-solving abilities.
Senior Pharmaceutical Quality Assurance Manager
Posted 6 days ago
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Job Description
Key Responsibilities:
- Developing, implementing, and maintaining a comprehensive Quality Management System (QMS) in compliance with cGMP, ICH, and other relevant regulatory guidelines.
- Leading and managing the QA team, providing guidance, mentorship, and performance management.
- Overseeing all QA activities, including batch record review and release, deviation investigations, CAPA management, change control, and document control.
- Conducting internal audits and participating in external regulatory inspections (e.g., FDA, EMA, WHO) and customer audits.
- Ensuring that all manufacturing and laboratory operations comply with approved procedures and regulatory standards.
- Reviewing and approving validation protocols and reports for manufacturing processes, equipment, and analytical methods.
- Managing supplier qualification programs and conducting audits of key raw material and component suppliers.
- Developing and delivering quality training programs for personnel involved in pharmaceutical operations.
- Monitoring quality metrics and key performance indicators (KPIs), identifying trends, and implementing continuous improvement initiatives.
- Investigating product quality complaints and ensuring timely and effective resolution.
- Acting as a key point of contact for regulatory bodies regarding quality matters.
- Staying abreast of evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
- Contributing to the strategic direction of the company's quality initiatives.
- Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A PhD is a plus.
- Minimum of 8-10 years of progressive experience in Quality Assurance within the pharmaceutical industry, with at least 3 years in a managerial or supervisory role.
- Extensive knowledge of current Good Manufacturing Practices (cGMP) and global pharmaceutical regulatory requirements.
- Proven experience with regulatory submissions, inspections, and successful interactions with health authorities.
- Demonstrated ability to lead and develop a high-performing QA team.
- Strong understanding of pharmaceutical manufacturing processes, quality control, and validation principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional communication, interpersonal, and negotiation skills.
- Proficiency in quality management software and data analysis tools.
- Strong project management skills and the ability to manage multiple priorities effectively.
- Experience with sterile product manufacturing or biologics is highly desirable.
Senior Pharmaceutical Quality Assurance Manager
Posted 6 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and maintain robust quality assurance policies, procedures, and systems in compliance with global regulatory standards (e.g., FDA, EMA, WHO GMP).
- Oversee all aspects of the Quality Management System (QMS), including change control, deviation management, CAPA (Corrective and Preventive Actions), and document control.
- Lead and mentor the QA team, providing guidance, training, and performance management.
- Plan and conduct internal audits of manufacturing, laboratory, and warehousing operations to ensure compliance.
- Manage external audits and inspections by regulatory authorities, acting as a primary point of contact.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Investigate quality complaints, deviations, and non-conformances, identifying root causes and implementing effective corrective actions.
- Ensure that all processes and products adhere to cGMP principles and company quality standards.
- Collaborate with R&D, manufacturing, and other departments to ensure quality is integrated throughout the product lifecycle.
- Stay updated on evolving regulatory requirements and industry best practices, implementing necessary changes to systems and procedures.
- Drive a culture of quality excellence throughout the organization.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8-10 years of progressive experience in pharmaceutical Quality Assurance or Quality Control.
- Extensive knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in managing a QA department and leading audit/inspection readiness activities.
- Demonstrated ability in developing and implementing QMS components such as change control, deviations, and CAPA.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent leadership, communication, and interpersonal skills.
- Experience in interacting with regulatory agencies during inspections.
- Ability to interpret complex regulatory guidelines and translate them into actionable procedures.
- Meticulous attention to detail and a commitment to maintaining high-quality standards.
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Senior Pharmaceutical Quality Assurance Manager
Posted 11 days ago
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Job Description
Your responsibilities will include developing, implementing, and maintaining the Quality Management System (QMS) in accordance with global regulatory requirements (e.g., FDA, EMA, WHO GMP). You will manage and conduct internal and external audits, ensuring compliance across all departments. This involves reviewing and approving batch records, investigating deviations and out-of-specification (OOS) results, and implementing corrective and preventive actions (CAPA). You will also be involved in supplier qualification and management, ensuring the quality of raw materials and components.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field, with a minimum of 7-10 years of progressive experience in pharmaceutical Quality Assurance. Proven experience in leading QA teams, managing audits, and implementing QMS and CAPA systems is essential. A deep understanding of GMP regulations, validation principles, and pharmaceutical manufacturing processes is required. Strong analytical, problem-solving, and decision-making skills are crucial. Excellent communication and leadership abilities are necessary to collaborate effectively with cross-functional teams and regulatory agencies.
This is a hybrid position, based near **Bhubaneswar, Odisha, IN**. While a significant portion of your work will involve on-site presence at manufacturing facilities for inspections, audits, and team oversight, you will also have the flexibility to manage documentation, analysis, and remote team coordination from a home office. This role requires a hands-on approach combined with strategic oversight to ensure unwavering product quality and regulatory compliance.
Responsibilities:
- Lead and manage the Quality Assurance department and its functions.
- Develop, implement, and maintain the Quality Management System (QMS).
- Ensure compliance with GMP, ICH, and other relevant regulatory guidelines.
- Conduct and oversee internal and external (supplier) audits.
- Review and approve batch records, specifications, and validation protocols.
- Investigate deviations, out-of-specification (OOS) results, and customer complaints.
- Implement and track Corrective and Preventive Actions (CAPA).
- Manage supplier qualification and ongoing supplier quality monitoring.
- Oversee product release processes.
- Provide QA support for product development, manufacturing, and lifecycle management.
- Train personnel on quality systems and GMP requirements.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Microbiology, or a related field.
- Minimum of 7-10 years of experience in pharmaceutical Quality Assurance.
- Proven experience in a managerial or leadership role within QA.
- Extensive knowledge of GMP regulations and quality systems.
- Experience with audits, validation, and deviation management.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in quality risk management principles.
- Ability to work effectively in a hybrid model, balancing on-site and remote duties.
Senior Pharmaceutical Quality Assurance Manager
Posted 12 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in compliance with global regulatory standards (e.g., FDA, EMA, WHO GMP).
- Oversee all aspects of pharmaceutical quality assurance, including batch record review, deviation management, change control, and CAPA (Corrective and Preventive Actions).
- Conduct internal and external audits of manufacturing sites, contract manufacturing organizations (CMOs), and suppliers to ensure compliance.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Ensure the quality and integrity of raw materials, in-process materials, and finished products through robust testing and inspection protocols.
- Prepare for and participate in regulatory inspections, serving as a key point of contact.
- Investigate product quality complaints and non-conformances, implementing effective root cause analysis and corrective actions.
- Train and mentor QA staff and other relevant personnel on quality principles and procedures.
- Contribute to product development and lifecycle management by providing quality assurance expertise.
- Stay updated on evolving regulatory guidelines and industry best practices in pharmaceutical quality assurance.
- Manage quality-related documentation and records, ensuring accuracy and completeness.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in the pharmaceutical industry, with at least 4 years in a Quality Assurance or Quality Control role.
- Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Distribution Practices (GDP).
- Proven experience in developing and implementing QMS, managing audits, and handling regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes, analytical testing, and product development.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and commitment to accuracy.
- Strong written and verbal communication skills, with the ability to effectively interact with regulatory bodies and internal stakeholders.
- Demonstrated ability to work independently and manage a remote team effectively.
- Experience with quality risk management principles is a plus.
Senior Quality Assurance Manager (Remote)
Posted 13 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with relevant industry standards (e.g., ISO 9001).
- Establish quality control procedures and guidelines for all stages of the manufacturing process, from raw material inspection to finished product testing.
- Oversee and manage the internal and external audit processes, ensuring compliance and identifying areas for improvement.
- Lead root cause analysis for quality defects and implement corrective and preventive actions (CAPA).
- Develop and track key quality metrics and KPIs, providing regular reports to senior management.
- Train and mentor quality assurance personnel, fostering a culture of quality consciousness throughout the organization.
- Collaborate with R&D, production, and supply chain teams to ensure product quality and consistency.
- Manage the supplier quality program, including supplier audits and performance evaluations.
- Stay current with industry trends, regulations, and best practices in quality assurance.
- Drive continuous improvement initiatives to enhance product quality and reduce waste.
- Champion a proactive approach to quality management, focusing on prevention rather than detection.
- Ensure all documentation related to quality control is accurate, complete, and maintained meticulously.
- Bachelor's degree in Engineering (Mechanical, Industrial, or relevant discipline), or a related technical field.
- Minimum of 7 years of progressive experience in quality assurance or quality control within a manufacturing environment.
- Proven experience in developing and implementing QMS, preferably with ISO 9001 certification.
- Strong knowledge of statistical process control (SPC), Six Sigma, and Lean Manufacturing principles.
- Excellent analytical and problem-solving skills with a meticulous attention to detail.
- Demonstrated leadership abilities and experience in managing remote teams.
- Effective communication, interpersonal, and presentation skills.
- Proficiency in quality management software and data analysis tools.
- Experience with product validation and verification processes.
- Commitment to maintaining the highest standards of product quality and customer satisfaction.