Senior Manager, Quality Assurance

2 weeks ago

Coimbatore, Tamil Nadu, India beBeeQuality Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Job Title:

We are seeking an experienced professional to lead our GMP Quality Assurance Operations. The successful candidate will be responsible for ensuring the quality and compliance of manufactured products, working closely with our CMC team to drive continuous improvement.

Key Responsibilities:

  • Review and approve batch records, deviations, CAPAs, change controls, and audit reports to ensure adherence to regulatory standards.
  • Perform technical reviews of Quality Control records, including certificates of release, analytical protocols, reports, and stability reports.
  • Support the Annual Product Quality Review and contribute to the development of QA Operations SOPs and other quality documents.
  • Ensure quality oversight of Contract Manufacturing Organizations (CMOs) through periodic site visits and remote collaboration.
  • Prepare and execute quality agreements, conduct vendor/CMO audits, and provide quality representation on external project teams.
  • Coordinate and manage compliance activities in preparation for regulatory and internal inspections.

Qualifications:

  • Bachelor's degree in a relevant field, such as Life Sciences, Pharmacy, Chemistry, or Engineering.
  • At least 13 years of experience in quality assurance roles in the pharmaceutical industry, with at least 5 years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.
  • Strong knowledge of FDA regulations (21 CFR, 210/211), ICH guidelines, and global regulations, as well as expertise in cGMP requirements pertaining to manufacturing and packaging operations.
  • Proven experience in conducting GMP audits and inspections is preferred.

Benefits:

Our organization offers a competitive compensation package, opportunities for career growth, and a dynamic work environment that values innovation and teamwork.

What We Offer:

We offer a range of benefits to support the well-being of our employees, including comprehensive health insurance, retirement plans, and paid time off.

How to Apply:

To apply for this position, please submit your resume and a cover letter explaining your qualifications and interest in the role.

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