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Executive QA Documentation
Zentiva
Ankleshwar, IND
Full-time
Mid · 1+ years experience
Onsite
Discovered 3 weeks ago
cGMPGDPQuality SystemsDocument Control SystemsAPQR
Free
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cGMPGDPQuality Systems
Key Skills for This Role
cGMPGDPQuality SystemsDocument Control SystemsAPQR
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Qualifications & Experience
- Educational Qualification
- Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
Experience
1–5 years of relevant experience in Pharma Quality Assurance / Documentation
Skills & Competencies
- Strong knowledge of cGMP, GDP, and Quality Systems
- Hands-on experience with batch documentation and document control systems
- Good understanding of APQR preparation and regulatory expectations
- Strong analytical, organizational, and coordination skills
- Effective communication and cross-functional collaboration abilities
- Attention to detail and commitment to data integrity
- Key Responsibilities
Review of Master Documents
Review and maintain Master Batch Manufacturing Records and Master Batch Packing Records to ensure accuracy, regulatory compliance, and alignment with approved specifications and process related changes.
Coordinate with Production, QC, and Regulatory Affairs for timely updates and approvals.
Annual Product Quality Review (APQR)
Prepare, compile, and review Annual Product Quality Reviews (APQRs) in line with regulatory expectations.
Support identification of improvement opportunities and follow-up of CAPAs arising from APQR findings.
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