Senior Quality Assurance Manager

110001 Delhi, Delhi ₹90000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a renowned pharmaceutical company recognized for its commitment to quality and innovation, is seeking a highly skilled and experienced Senior Quality Assurance Manager to oversee their operations in Delhi, Delhi, IN . This is a critical leadership role responsible for ensuring that all pharmaceutical products meet stringent regulatory standards and internal quality policies. The successful candidate will lead a team of QA professionals, manage the quality management system, and drive continuous improvement initiatives across all manufacturing and R&D processes. Key responsibilities include developing and implementing QA strategies, conducting internal audits, managing external audits by regulatory agencies, and ensuring compliance with cGMP, ICH guidelines, and other relevant regulations. You will play a pivotal role in risk assessment, deviation management, and CAPA implementation. We are looking for a proactive and detail-oriented leader with a deep understanding of pharmaceutical quality systems and regulatory affairs. The ability to foster a strong quality culture and mentor team members is essential. This position requires a strategic thinker with excellent analytical and problem-solving skills, coupled with strong leadership and communication abilities. The ideal candidate will have a proven track record of successfully managing QA operations in a pharmaceutical manufacturing environment. Responsibilities:
  • 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.
Qualifications:
  • 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.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹110000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client is seeking an experienced Senior Pharmaceutical Quality Assurance Manager to oversee quality systems and compliance for their operations in Delhi, Delhi, IN . This hybrid role involves a blend of on-site presence for critical oversight and team engagement, alongside remote work for strategic planning and documentation. You will be responsible for ensuring that all pharmaceutical products manufactured by our client meet the highest standards of quality, safety, and efficacy, adhering strictly to national and international regulatory requirements (e.g., GMP, ICH guidelines). Your responsibilities will include developing, implementing, and maintaining the Quality Management System (QMS), managing audits (internal and external), leading CAPA investigations, and ensuring thorough documentation control. The ideal candidate will possess strong leadership skills, a deep understanding of the pharmaceutical industry, and a meticulous approach to quality assurance. Responsibilities:
  • 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.
Qualifications:
  • 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.
This role offers a hybrid work model, combining essential on-site collaboration and oversight at our Delhi, Delhi, IN facility with the flexibility of remote work.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹90000 Monthly WhatJobs

Posted 3 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 critical quality systems and ensure compliance with regulatory standards. This is a hybrid role, demanding on-site presence for key audits and lab work at our **Delhi, Delhi, IN** facility, complemented by remote responsibilities for documentation review and strategic planning. You will be instrumental in maintaining the highest quality standards throughout the drug development and manufacturing lifecycle.

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.
Qualifications:
  • 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.
This is a crucial role for our client, impacting their ability to deliver safe and effective pharmaceuticals. If you are a highly motivated QA professional with a passion for upholding the highest standards of quality in **Delhi, Delhi, IN**, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1100000 Annually WhatJobs

Posted 3 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 enhance their Quality Management System. This critical role will oversee and manage all aspects of quality assurance for pharmaceutical product development, manufacturing, and distribution processes. The ideal candidate will possess a deep understanding of regulatory requirements (e.g., GMP, ICH guidelines) and a proven track record of implementing and maintaining robust quality systems. This is a hybrid position, requiring significant on-site presence at our **Delhi, Delhi, IN** facility for critical oversight, team collaboration, and facility audits, while allowing for remote work for specific tasks and reporting.

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.
Qualifications:
  • 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.
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Remote Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹95000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a leading name in the pharmaceutical industry, is actively seeking an experienced and detail-oriented Pharmaceutical Quality Assurance Manager for a fully remote position. This role is critical in ensuring that our client's pharmaceutical products consistently meet the highest standards of quality, safety, and efficacy. You will be instrumental in developing, implementing, and overseeing robust quality management systems that comply with national and international regulatory requirements. This is a remote-first role, emphasizing effective virtual collaboration and independent work ethic.

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.
Qualifications:
  • 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.
This vital role, impacting the pharmaceutical landscape from Delhi, Delhi, IN , offers the flexibility of remote work combined with the profound responsibility of safeguarding public health through uncompromising quality standards.
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1400000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client is seeking a highly experienced and dedicated Senior Pharmaceutical Quality Assurance Manager to lead their quality operations. This is a fully remote position, offering the flexibility to manage critical quality processes from anywhere. You will be responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensure compliance with global regulatory standards, including GMP, ICH guidelines, and FDA regulations. The ideal candidate possesses a comprehensive understanding of pharmaceutical manufacturing processes, validation principles, and regulatory affairs. Key responsibilities include overseeing all aspects of quality assurance, including batch record review, deviation management, CAPA implementation, change control, and internal/external audits. You will lead a team of QA professionals, providing guidance and mentorship to ensure consistent quality standards. Experience in risk management, quality risk assessments, and continuous improvement initiatives is essential. The role involves collaborating closely with manufacturing, R&D, and regulatory affairs departments to ensure product quality and compliance throughout the product lifecycle. We are looking for a candidate with a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field, coupled with a minimum of 7-10 years of progressive experience in pharmaceutical Quality Assurance. Strong leadership, excellent analytical, problem-solving, and communication skills are paramount. Our client is committed to upholding the highest standards of quality and safety, and this remote leadership role is crucial to achieving those objectives. This is an exceptional opportunity for a seasoned QA professional to drive quality excellence in a dynamic, fully remote setting.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹2200000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a globally recognized pharmaceutical company, is seeking a highly accomplished Senior Pharmaceutical Quality Assurance Manager to oversee critical quality systems and ensure regulatory compliance within their operations in Delhi, Delhi, IN . This role demands a rigorous approach to quality management, encompassing the entire product lifecycle from development to post-market surveillance. You will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS) in adherence to global regulatory standards such as GMP, ICH, and FDA guidelines. Key responsibilities include managing and conducting internal and external audits, ensuring readiness for regulatory inspections, and overseeing CAPA (Corrective and Preventive Actions) implementation. You will lead the QA team, providing guidance, mentorship, and performance management. Your expertise will be crucial in reviewing and approving batch records, validation protocols, and change control documentation. You will also play a significant role in regulatory submissions, technical transfer processes, and risk management activities. Proactively identifying quality risks and implementing robust mitigation strategies is paramount. Collaboration with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Supply Chain, is essential to embed quality throughout the organization. The ideal candidate will possess a Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life sciences field, with a minimum of 10 years of progressive experience in pharmaceutical quality assurance. A strong track record of successfully managing QA operations and ensuring compliance in a GMP environment is mandatory. Deep knowledge of regulatory requirements and a comprehensive understanding of pharmaceutical manufacturing processes are essential. Excellent leadership, analytical, problem-solving, and decision-making skills are required. Exceptional written and verbal communication abilities are necessary for effective interaction with regulatory bodies and internal stakeholders. This is an unparalleled opportunity to contribute to the quality and safety of life-saving medicines within a leading pharmaceutical organization.
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹130000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to lead their quality assurance and compliance efforts. This critical role is responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements. As a fully remote position, you will oversee QA operations, develop and implement robust quality management systems, and drive continuous improvement initiatives across all stages of drug development and manufacturing. Your expertise in pharmaceutical regulations and your commitment to quality will be instrumental in maintaining our client's reputation for excellence.
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.
This is an outstanding opportunity for a seasoned QA professional to lead and shape quality initiatives within a progressive pharmaceutical organization, operating remotely from Delhi, Delhi, IN .
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Senior Pharmaceutical Quality Assurance Manager

110001 Delhi, Delhi ₹1400000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly experienced and dedicated Senior Pharmaceutical Quality Assurance Manager to join their team. This is a hybrid role, offering a blend of remote work flexibility and essential in-office collaboration to ensure the highest standards of quality in pharmaceutical manufacturing and operations. The Senior QA Manager will be responsible for developing, implementing, and maintaining robust quality assurance systems in compliance with global regulatory requirements (e.g., GMP, ICH guidelines). You will oversee quality control processes, manage deviations and CAPAs, conduct internal audits, and ensure the overall quality of pharmaceutical products. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, regulatory affairs, and quality management principles. You will collaborate closely with manufacturing, R&D, regulatory, and supply chain teams to foster a strong quality culture. This role demands exceptional leadership, analytical thinking, and problem-solving skills, along with meticulous attention to detail. You will be expected to lead quality audits, manage a team of QA professionals, and ensure the continuous improvement of quality systems. We are looking for a proactive, ethical, and results-driven individual who can effectively drive quality initiatives and uphold the integrity of our pharmaceutical products. Experience with pharmaceutical validation and GxP compliance is critical.

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.
Qualifications:
  • 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.
This role is hybrid and based in Delhi, Delhi, IN .
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