256 Quality Assurance Manager jobs in Delhi
Senior Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with global regulatory standards.
- Lead and mentor the Quality Assurance team, fostering a culture of quality and compliance.
- Oversee and manage all aspects of regulatory compliance, including cGMP, ICH guidelines, and local regulations.
- Plan and execute internal audits and host regulatory agency inspections.
- Manage deviation investigations, root cause analysis, and the implementation of Corrective and Preventive Actions (CAPA).
- Review and approve batch records, validation protocols, and other critical quality-related documentation.
- Conduct risk assessments to identify and mitigate potential quality issues.
- Collaborate with R&D, Manufacturing, and other departments to ensure product quality and process consistency.
- Stay updated on evolving regulatory requirements and industry best practices.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Proven experience in managing a QA team and QMS.
- Strong understanding of pharmaceutical manufacturing processes, validation, and documentation.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills.
- Experience with regulatory inspections and audits is essential.
Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
- Developing and implementing comprehensive Quality Management Systems (QMS).
- Ensuring compliance with all relevant pharmaceutical regulations (e.g., GMP, GDP).
- Managing and conducting internal and external audits, and hosting regulatory inspections.
- Leading investigations into deviations, non-conformances, and customer complaints, and implementing CAPA plans.
- Reviewing and approving batch records, validation protocols, and other critical documentation.
- Overseeing the qualification and validation of equipment, processes, and analytical methods.
- Managing change control processes and ensuring robust risk management strategies are in place.
- Training and mentoring QA personnel and contributing to the quality culture across the organization.
- Collaborating with Production, R&D, and Regulatory Affairs departments to ensure seamless quality integration.
- Staying updated on evolving regulatory requirements and industry best practices.
- Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 7-10 years of experience in Pharmaceutical Quality Assurance/Quality Control.
- Extensive knowledge of GMP, ICH guidelines, and other relevant regulatory frameworks.
- Proven experience in managing audits, regulatory inspections, and CAPA systems.
- Strong leadership, analytical, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to effectively interact with all levels of management and regulatory bodies.
- Experience in document control and change management.
- Ability to work effectively in both an on-site and remote capacity.
- Detail-oriented with a commitment to maintaining the highest quality standards.
- Experience with serialization and track-and-trace systems is a plus.
Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and manage robust Quality Assurance (QA) systems and procedures in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Lead and participate in internal and external audits, inspections, and quality assessments.
- Oversee the review and approval of batch records, validation protocols, and other critical quality documentation.
- Manage deviation investigations, root cause analysis, and the implementation of corrective and preventive actions (CAPAs).
- Ensure the quality and compliance of raw materials, in-process materials, and finished products.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure quality by design principles are integrated.
- Develop and deliver training programs to QA personnel and other stakeholders on quality systems and regulatory requirements.
- Monitor and assess the performance of quality control laboratories and contract manufacturers.
- Stay current with evolving regulatory requirements and industry best practices in the pharmaceutical sector.
- Lead continuous improvement initiatives to enhance the overall quality management system.
- Manage the change control process, ensuring all changes are properly assessed and documented.
- Prepare and present QA reports to senior management, highlighting key quality metrics and potential risks.
- Champion a culture of quality and compliance throughout the organization.
- Act as a key point of contact for regulatory agencies during inspections.
- Review and approve Standard Operating Procedures (SOPs) and other controlled documents.
- Master's or PhD in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 8 years of progressive experience in Quality Assurance within the pharmaceutical industry, with a significant focus on GMP compliance.
- In-depth knowledge of pharmaceutical manufacturing processes, quality control, and regulatory affairs.
- Proven experience in leading audits, investigations, and CAPA management.
- Strong understanding of global regulatory requirements (e.g., US FDA, EMA, CDSCO).
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal abilities.
- Demonstrated experience in a hybrid work environment, effectively managing responsibilities across remote and on-site settings.
- Proficiency in using quality management software and electronic documentation systems.
- Ability to manage multiple projects and prioritize effectively.
- Strong scientific acumen and attention to detail.
- Experience with drug product development and lifecycle management is a plus.
Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) programs and systems in compliance with national and international pharmaceutical regulations.
- Oversee and manage all QA activities, including batch record review, deviation investigations, CAPA management, change control, and risk assessments.
- Conduct internal and external audits (e.g., vendor qualification, supplier audits) to ensure compliance and identify areas for improvement.
- Review and approve essential quality-related documents, including SOPs, validation protocols, and batch manufacturing records.
- Ensure all manufacturing processes and finished products meet established quality standards and regulatory requirements.
- Lead and mentor the QA team, providing guidance, training, and performance management.
- Collaborate with other departments, including Manufacturing, R&D, Regulatory Affairs, and Supply Chain, to ensure quality is integrated throughout the product lifecycle.
- Manage regulatory inspections and respond to inquiries from health authorities.
- Participate in the development and validation of new manufacturing processes and equipment.
- Stay updated on current Good Manufacturing Practices (cGMP) and other relevant regulatory guidelines, ensuring the company remains compliant.
- Drive continuous improvement initiatives within the QA department and the broader organization.
- Prepare and present quality metrics and reports to senior management.
- Master's degree or Ph.D. 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, ICH guidelines, and other relevant pharmaceutical regulatory requirements.
- Proven experience in managing quality systems, including deviation investigations, CAPA, change control, and audits.
- Strong understanding of pharmaceutical manufacturing processes and product development.
- Excellent leadership, team management, and interpersonal skills.
- Exceptional analytical, problem-solving, and decision-making abilities.
- Strong written and verbal communication skills, with the ability to effectively interact with regulatory agencies and internal stakeholders.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Proficiency in using quality management software and standard office applications.
- Experience with regulatory submissions and inspections is highly desirable.
Remote Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with cGMP, ICH, and other relevant regulatory guidelines.
- Oversee and manage all aspects of pharmaceutical product quality, from raw material sourcing to finished product release.
- Conduct internal audits and facilitate external regulatory inspections (e.g., FDA, EMA).
- Investigate deviations, customer complaints, and out-of-specification (OOS) results, implementing corrective and preventive actions (CAPA).
- Review and approve batch records, validation protocols, and other critical quality documents.
- Develop and manage quality control testing strategies and protocols.
- Train and mentor QA/QC staff on quality procedures and regulatory compliance.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure seamless product development and lifecycle management.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Manage the supplier qualification and audit program.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
- Minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory submission processes.
- Proven experience in conducting audits and managing regulatory inspections.
- Strong understanding of pharmaceutical manufacturing processes and validation principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication abilities.
- Demonstrated ability to lead teams and manage projects effectively in a remote setting.
- Proficiency in quality management software and tools.
- Experience with sterile manufacturing and aseptic processing is a plus.
Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
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Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with relevant pharmaceutical regulations (e.g., GMP, GLP, GCP).
- Oversee all aspects of quality assurance, including batch record review, deviation management, change control, and CAPA (Corrective and Preventive Actions).
- Conduct internal audits and host regulatory inspections (e.g., FDA, WHO, DCGI).
- Manage and train the Quality Assurance team, fostering a culture of quality and compliance.
- Ensure that all raw materials, in-process materials, and finished products meet established specifications.
- Review and approve validation protocols and reports for equipment, processes, and analytical methods.
- Stay updated on current pharmaceutical regulations and industry best practices, ensuring company-wide compliance.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure quality is integrated throughout the product lifecycle.
- Investigate quality complaints and product deviations, implementing appropriate corrective actions.
- Prepare and present quality metrics and reports to senior management.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Ph.D. is a plus.
- Minimum of 8 years of experience in the pharmaceutical industry, with a significant focus on Quality Assurance and Quality Control.
- In-depth knowledge of GMP, GLP, GCP, and other relevant pharmaceutical regulatory guidelines.
- Proven experience in developing and managing Quality Management Systems.
- Experience with regulatory audits and inspections.
- Strong leadership, communication, and interpersonal skills.
- Excellent analytical and problem-solving abilities, with meticulous attention to detail.
- Proficiency in relevant software applications, including QMS software.
- Ability to work independently, manage multiple priorities, and meet deadlines in a remote work environment.
- Experience in pharmaceutical manufacturing processes is highly desirable.
Senior Pharmaceutical Quality Assurance Manager
Posted 3 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) systems and procedures.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements.
- Oversee quality control activities, including batch record review and release.
- Manage deviations, Out-of-Specification (OOS) results, and Corrective and Preventive Actions (CAPAs).
- Conduct internal audits and support external regulatory inspections.
- Review and approve validation protocols and reports for equipment, processes, and systems.
- Provide QA oversight for pharmaceutical manufacturing and packaging operations.
- Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.
- Train and mentor QA personnel.
- Stay current with evolving regulatory requirements and industry best practices.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related science field.
- Minimum of 7 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- In-depth knowledge of cGMP, ICH guidelines, and other relevant pharmaceutical regulations.
- Proven experience in developing and implementing QA systems.
- Strong understanding of pharmaceutical manufacturing processes and quality control.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional leadership, communication, and interpersonal skills.
- Ability to manage multiple projects and priorities effectively.
- Experience with validation and GxP compliance is essential.
- Detail-oriented with a commitment to quality and compliance.