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Jubilant Enpro
posted 14hr ago
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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 Company s 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 Associate Director- QA
Location- Nanjangud, Mysore
Job Context:
The PVQA is responsible for managing, maintaining, further developing and implementing globally aligned quality processes to ensure PV system is in compliance with applicable pharmacovigilance regulations and requirements.
Challenges:
Overall management of audit program, including conducting of internal and external PV audits
SOPs, Guidance and Support
- Provide GVP / local PV legislation and process related guidance and support.
- Perform GVP review of new / updated GxP related Standard Operating Procedures and Working Instructions.
Identification, Assessment and Initiatives
- Identification and continuous assessment of key quality indicators of the PV system, identification of key quality issues and escalation accordingly.
- Responsible for leading the QA preparation, management and follow up for all PV Health authority inspections.
- Plan initiatives focused on PV quality, process and compliance improvement.
Development and effective execution of annual PV audit program dedicated to Jubilant s Pharmacovigilance systems, processes and activities
- Create Strategic and Tactical audit plans as per GVP Module IV.
- Perform internal audits related to PV systems and processes as per Operational audit plan;
- Conduct external audits (affiliates and external SDEA partners) of Jubilant PV stakeholders as per signed annual vendor audit schedule;
- Perform PV subcontractor audits and periodically evaluate their quality level with regards to Jubilant PV requirements and applicable regulations and coordinate the qualification of external PV partners.
- Write Audit reports according to applicable procedures and review proposed Corrective and Preventive Actions as applicable;
- Follow up all audit reports for completion of corrective actions and ensure timely implementation and closure of audit reports
- Ensure inspection readiness of the PV Quality Management System including preparation, support and follow up of inspections conducted by Competent Authorities.
Quality Management & Systems
- Contribute to the quality training of PV employees by developing training materials or facilitating training.
- Review Change controls raised by PV team
- Support PV Department in the investigation of deviations related to PV processes and provide quality input into the development of CAPA plans;
- Ensure appropriate documentation of any non-compliance impacting the PV System in a defined format.
- Provide inputs during PSMF periodic reviews
- Supporting for the implementation & performed assigned activities for QA computerized systems.
Quality Culture
- Foster a PV quality culture in Corporate and Affiliates organizations by providing advice from a PV quality perspective;
Functional Skills :
- Knowledge of Validation Guidelines
- Exposure of Software Validations
- Exposure towards regulatory audits like MHRA / USFDA /TGA / MCC / ANVISA
- Significant and successful contribution in Quality Management, CAPA Management, Vendor Management and Process improvement
Behavioral Skills :
- Good Communications skills, Management skills, Leadership skills
- Problem solving skills
- Willing to learn new methods and system
- Sound judgement and decision making
Person Profile.
Education Qualification: B Pharma / M.Sc. / M Pharma
Experience Range : 10-12 years
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
No travel
Day Shift
Jubilant Enpro Benefits
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