15h Left: Executive

Job Description Role & Responsibilities: - 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 strong 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.