Pharma Documentation Specialist

Prepare, review, revise, and maintain SOPs, batch records, protocols, reports, specifications, and controlled documents.

Manage Master Batch Manufacturing Records (MBMR/MFR) and Master Packaging Records (MPR).

Review batch documentation for accuracy, completeness, and GMP compliance.

Maintain document revision history, issuance, retrieval, and archival records.

Coordinate document review and approval with QA, QC, Production, Regulatory Affairs, and other departments.

Support Change Control, CAPA, deviations, and document-related investigations.

Maintain document-control logs and electronic document management systems.

Ensure current and approved versions of documents are available to relevant departments.

Support internal audits and regulatory inspections by retrieving required documentation.

Assist with APQR/PQR and other quality documentation where required.

Ensure proper Good Documentation Practices (GDP) and data integrity.

Track document expiry, periodic review, and timely revision