Job
Description
Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Companys Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules. 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: Review and analyse the failures at manufacturing sites to have appropriate investigations, assessing the impact based on the nature of event/risk analysis to derive appropriate mitigation plans including CAPA to avoid reoccurrence. Communications Communicate with external and internal customers in a timely manner, as required. Ensure effective communication between all members of QA department and staff of other department. Functional Skill Significant and successful contribution in Quality Management, CAPA Management, Vendor Management and Process improvement Experienced in conducting audits manufacturing sites and external suppliers. Person Profile. Education Qualification: Post Graduate in Science/ Doctorate Experience Range : 10+ years in QA Vendor Management & Risk assessment Show more Show less
