Key Responsibilities1. Quality System Management and Compliance:Implement, maintain, and monitor the company's Quality Management System (QMS) as it relates to API manufacturing.Ensure all processes, procedures, and documentation comply with cGMP, regulatory guidelines, and corporate policies.Conduct routine inspections and on-line process checks to ensure adherence to standard operating procedures (SOPs) and batch records.Participate in internal and external audits (e.g., by regulatory bodies, customers, and third-party auditors).Assist in the preparation and review of responses to audit findings and ensure the timely implementation of corrective actions.2. Documentation and Record Keeping:Review and approve manufacturing and quality control documents, including Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), raw material and finished product specifications, and Certificates of Analysis (CoAs).Draft, review, and revise Standard Operating Procedures (SOPs), protocols, and other quality-related documents.Manage and control all quality-related documentation, ensuring proper version control, storage, and retrieval.Ensure accurate and complete documentation for all quality assurance activities, including deviations, change controls, and CAPAs.3. Investigations and Quality Events:Initiate, investigate, and close deviations, incidents, and non-conformances in a timely and effective manner.Perform root cause analysis (RCA) for quality events and recommend appropriate Corrective and Preventive Actions (CAPA).Monitor the implementation and effectiveness of CAPAs to prevent recurrence.Assist in the investigation and resolution of market complaints and product recalls.Review Out of Specification (OOS) and Out of Trend (OOT) results, and coordinate with the Quality Control (QC) and Production departments to conduct thorough investigations.4. Validation and Qualification:Participate in the review and approval of validation protocols and reports for equipment, processes, and cleaning.Ensure that all critical equipment and systems are qualified and maintained in a validated state.Review and approve documents related to the qualification of new and existing vendors and suppliers.5. Training and Continuous Improvement:Provide training to manufacturing and other relevant personnel on GMP regulations and quality procedures.Foster a culture of quality awareness and continuous improvement within the organization.Identify opportunities for process and quality system improvements and participate in their implementation.
