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Executive QA Documentation

Zentiva
Ankleshwar, IND
Full-time
Junior · 1–5 years experience
Onsite
Discovered 3 weeks ago

Full Job Posting

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.

Responsibilities

  • 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.
  • 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.
  • Coordinate and monitor cGMP and quality-related training programs for site personnel.
  • Maintain trainingschedules, records, and effectiveness assessments.
  • 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.

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