Quality Assurance

6 hours ago

Ahmedabad Gujarat, India Swastik Placement Agency Full time

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.

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

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