Deputy Manager-Quality Assurance

Job Description

The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Find out more about us at www.jubilantpharmova.com . The Position Organization- Jubilant Pharmova Limited Designation- Deputy Manager-Quality Assurance - Vendor Management & Risk assessment Location- Nanjangud, Mysore Shall be responsible for the following activities: Perform Vendor audits to ensure compliance with applicable regulatory guidelines and Standard Operating Procedures. Liaison with manufacturing unit Jubilant Generics Ltd. staff to assure that quality plans/goals/initiative are understood and implemented. Challenges: To be responsible for consistently upgrading and up keeping of procedures aligned with regulatory standards and regulatory compliance levels. Scope of work QA Authentication: Protocol/procedural requirements verification. Internal and External audits Provide technical and regulatory inputs in development and application of procedures, training materials, communications, and/or tools. Documentation: Initiate procedural changes as and when required. Prepare audit reports. Evaluate regulatory update received and shared with manufacturing unit for their evaluation and impact assessment. Assist senior management in preparation of various trends and their evaluation. Internal Audits/Vendor Audits: Up keeping of systems and procedural compliance for assurance through Internal System/Facility audits/spot audits Vendor audits for key services to have uniform quality and assurance. Investigations, Impact Assessment, Risk Analysis, Mitigation/CAPA: