Senior Manager QC Lab

Amneal Pharmaceuticals; India; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a senior QC laboratory leader to supervise testing activities and ensure GMP/GLP compliance across processes.

The role focuses on reviewing analytical results, leading investigations of deviations, driving CAPA and continuous improvement, and mentoring QC teams to uphold regulatory readiness and data integrity. You will coordinate internal and regulatory audits, approve COAs, and guide calibration and equipment maintenance in the sampling room.

Qualifications

• 15+ years of experience in QA/QC in pharmaceutical/biotech settings.
• Experience leading QC laboratory teams and audits.
• Strong knowledge of GMP/GLP and regulatory requirements.
• Ability to drive CAPA and continuous improvement.
• Auditing preparedness for internal and regulatory audits.

Responsibilities

• Supervise QC laboratory operations and testing activities
• Review and interpret in-process and finished product analytical results
• Ensure compliance with GMP, GLP, and regulatory requirements
• Identify quality trends, risks, and recurring laboratory issues
• Approve or reject materials and products based on analytical outcomes
• Audit and monitor manufacturing and QC processes for compliance
• Review and approve analytical data, COAs, and laboratory documentation
• Lead investigations of deviations, OOS/OOT, and non-conformances
• Drive CAPA effectiveness and continuous improvement initiatives
• Prepare teams for internal, external, and regulatory audits
• Mentor, develop, and manage QC laboratory leadership teams
• Responsible for the operation & calibration of balances in Sampling room & to maintain its record.

Education

MSc / MA (MS/MA) in science

M.Pharm preferred

Job description

Job Description:

Essential Functions:

• Supervise QC laboratory operations and testing activities
• Review and interpret in-process and finished product analytical results
• Ensure compliance with GMP, GLP, and regulatory requirements
• Identify quality trends, risks, and recurring laboratory issues
• Approve or reject materials and products based on analytical outcomes
• Audit and monitor manufacturing and QC processes for compliance
• Review and approve analytical data, COAs, and laboratory documentation
• Lead investigations of deviations, OOS/OOT, and non-conformances
• Drive CAPA effectiveness and continuous improvement initiatives
• Prepare teams for internal, external, and regulatory audits
• Mentor, develop, and manage QC laboratory leadership teams

Additional Responsibilities:

• Responsible for the operation & calibration of balances in Sampling room & to maintain its record.

Qualifications

Education:

• Master Degree (MS/MA) M. Sc. - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 15 years or more in 15+ Years