Chief Manager - Quality Assurance

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com Job Title Chief Manager - Quality Assurance Job Description This role is Responsible for ensuring compliance with cGMP guidelines in the manufacturing and quality control. The role includes approving quality procedures, specifications, and batch records, as well as reviewing QMS elements such as Change Control, Deviation, CAPA, OOS/OOT, complaints, returns, and recalls. The incumbent will also ensure proper investigation and closure of quality issues, conduct internal audits, and perform vendor evaluation for raw and packaging materials to maintain quality standards. Release or rejection of all APIs.Establishment of system as per CGMP to release or reject raw materials, intermediate packaging and labelling materials.Approving all procedures impacting the quality of intermediates or APIs.Review & approval of the QMS elements like Change Control. Deviation, CAPA, OOT, Customer Complaint, Return Goods & Recall.Final review and authorization of completed batch production laboratory control record before release of the API for distribution.Ensure all deviations, OOS, OOT are properly investigated and closed.Approving all specifications and master production instruction.Approving all the procedures that potentially impacting the quality of Raw materials. Intermediate and APIs.Conducting Internal Audits (Self-Inspections).Making sure that internal audits (Self-Inspections) are performed.Conduct vendor evaluation of Raw Material & Packaging materials.Ensure Customer Complaints, Return Goods & Product Recall are properly investigated and closed.Reviewing and approving validation protocols and reports. Review and approving all the changes that potentially impact intermediate or API quality. Make sure that effective systems are used for maintaining and calibrating critical equipment. Make sure that materials are appropriately tested and results are reported. Make sure that there is stability data to support retest or expiry dates and storage condition on APIs and/or intermediate where appropriate. I Approval of Preventive Maintenance & Calibration of equipment and systems. Performing product quality reviews. Ensure the compliance of all the system as per CGMP requirements. Facing Customer and regulatory Audits. Ensure timely responses to the customer and regulatory queries. .