Executive

1. Maintain and control SOPs, protocols, reports, formats and other QA documents.

2. Ensure preparation, review, approval, issuance and distribution of controlled documents.

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

4. Ensure timely review and revision of SOPs and other controlled documents.

5. Maintain proper documentation practices as per cGMP and ALCOA+ guidelines.

6. Coordinate with various departments for document preparation, review and approval.

7. Maintain document master lists and ensure obsolete documents are withdrawn.

8. Handle document retrieval during internal audits, external audits and regulatory inspections.

9. Maintain training records related to SOP revisions and new document implementation.

10. 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.