Executive QA Documentation
Zentiva · zentiva.cz
AnkleshwarEntry level1–5 yrs
The job in short
QA documentation.
PharmacyCompliance
Details
- Found
- 25 d ago · posted 2026-04-20
- Location as listed
- India / Ankleshwar
- Role
- Quality Engineer
- Source
- The company’s own careers site
Full description
Position Title: Executive QA Documentation
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.
cGMP Training Coordination
• Coordinate and monitor cGMP and quality-related training programs for site personnel.
• Maintain trainingschedules, records, and effectiveness assessments.
Archival & Records Retention
• Manage the archival room and document storage systems for controlled and historical GMP documents.
• Ensure secure storage, easy retrieval, retention compliance, and protection against unauthorized access or damage.
• Support audits and inspections by ensuring availability of archived records.