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Zentiva

Executive QA Documentation

Actively Reviewing

Zentiva

1–2 yrs exp Posted 1 month ago  · Apply by Jul 18, 2026
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.