- Manage and maintain all documentation related to Quality Management Systems (QMS), including validation, qualification, deviation, and change control activities.
- Prepare and review MFRs, SOPs, and AMV (Analytical Method Validation) documents in line with regulatory requirements.
- Prepare and compile regulatory dossiers in ACTD/CTD formats.
- Possess solid knowledge of COPP (Certificate of Pharmaceutical Product) documentation and requirements.
- Prepare and file Batch Manufacturing Records (BMRs) and manage all FR&D; documentation activities.
- Monitor process validation activities and prepare corresponding protocols and reports.
- Oversee cleaning validation activities, including preparation and review of protocols and reports.
- Review qualification documents for equipment and facilities to ensure compliance with GMP standards.
- Review calibration records of instruments and equipment to ensure accuracy and traceability.
- Monitor and review revalidation of processes and requalification of instruments and equipment.
- Ensure all documentation complies with company policies, regulatory guidelines, and audit readiness standards.