About this role
- Maintain and control SOPs, protocols, reports, formats and other QA documents.
- Ensure preparation, review, approval, issuance and distribution of controlled documents.
- Maintain document issuance, revision history and archival records.
- Ensure timely review and revision of SOPs and other controlled documents.
- Maintain proper documentation practices as per cGMP and ALCOA+ guidelines.
- Coordinate with various departments for document preparation, review and approval.
- Maintain document master lists and ensure obsolete documents are withdrawn.
- Handle document retrieval during internal audits, external audits and regulatory inspections.
- Maintain training records related to SOP revisions and new document implementation.
- Ensure compliance with GDP (Good Documentation Practices) and data integrity requirements.
Required Qualifications
- B.Pharm / M.Pharm / B.Sc / M.Sc. Relevant experience in Quality Assurance – Documentation Control in a pharmaceutical formulation company.
- Required Experience 2–5 years in QA Documentation Control.
- Experience in OSD (Oral Solid Dosage) manufacturing preferred.
- Key Skills Knowledge of cGMP, GDP and ALCOA+.
- SOP preparation and document lifecycle management.
- Document issuance, archival and retrieval.
- Audit documentation handling.
- Good coordination and communication skills.
- Knowledge of MS Office.