Job Description

Key Responsibilities:

- Coordinate and compile Annual Product Quality Reviews for all commercial products

in accordance with regulatory requirements (e.g., EU GMP Part I, ICH Q7, ICH Q10).

- Collect and trend data from multiple departments: Production, QC, QA, Engineering,

and Regulatory Affairs.

- Analyze product quality trends, deviations, complaints, out-of-specification (OOS)

results, and CAPAs.

- Collaborate with cross-functional teams to gather accurate and complete

information.

- Prepare comprehensive APQR reports, highlighting key findings, trends, and

recommendations.

- Ensure timely completion of APQRs as per the internal schedule and regulatory

expectations.

- Identify potential areas for process improvement or quality enhancement.

- Support audits and inspections (regulatory, internal, customer) by presenting APQRs

and related data.

- Maintain up-to-date knowledge of regulatory guidelines and industry best practices.

Qualifications and Experience:

Education: Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or related

scientific discipline.

Experience:

- 2-5 years of experience in Quality Assurance within a regulated industry (preferably

pharmaceuticals or biotech).

- Hands-on experience with APQR preparation and data analysis.

- Strong knowledge of cGMP, ICH guidelines, and regulatory requirements.

- Proficiency in Microsoft Office (especially Excel, Word, and PowerPoint).

- Experience with electronic documentation systems (e.g., TrackWise, MasterControl)

is an advantage.

Job Type: Full-time

Pay: ₹30,000.00 - ₹40,000.00 per month

Schedule:

Day shift
Education:

Bachelor's (Preferred)
Experience:

Quality Assurance: 2 years (Preferred) regulated industry: 1 year (Preferred) APQR preparation: 1 year (Preferred) data analysis: 1 year (Preferred) cGMP, ICH guidelines: 2 years (Preferred) Pharma Industry: 2 years (Preferred)
Work Location: In person