Associate Director - CSV

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 – AssociateDirector – Computer System Validation

Location- Nanjangud, Mysore

Responsible to harmonize, ensure and standardize policies and procedures for computerized system validations and ensure effective implementation of the computerized system validation in coordination with corporate quality and with all departments of the plant with respect to Computer System Validation (CSV).

Responsible to assist site personnel / management in developing protocols, test cases, validation packages, etc. for validations of computerized system.

Responsible to evaluate validation requirement for computerized systems used for GxP purposes in various department of the plant.

Provide guidance on the interpretation of regulatory requirement and guidelines for GxP Computerized systems from regulatory agencies and organizations in relative to CSV / IT Compliance activities.

Responsible to review of CSV requirements in the validation protocols by defining the required test cases of IQ / OQ for computerized system of equipment's & instruments etc., and also tracking of CSV implementation.

Ensure the compliance-related issues handled independently aligned with the processes and controls on computerized systems.

Responsible to identify, communicate and manage compliance risks, breaches and issues, and monitor corrective action to mitigate the risk through risk assessment related to computerized systems.

Responsible to independently assess the regulatory compliance activities of computerized system e.g. GxP, FDA, Annex 11 etc.

To conduct internal reviews and compliance at site on GxP Computerized systems.

To assess and improve the cGMP practices and procedures on computerized system validations.

Responsible for data governance & management controls in reviewing complete, consistent, accurate, truthful and reliable data in all GxP Computerized systems required as per regulatory requirements.

Ensure all incidents related computerized systems are logged, tracked, monitored and closed after it has been detected.

Review and approval of equipment qualification and re-qualification documents and monitoring of equipment, utility and facility qualification activities.

Review and approval of equipment layouts and Piping & Instrument Diagrams (P&IDs).

Review and approval of Qualification Summary Report for the equipment.

Review of the engineering documents associated with SOP's.

Review of VMP schedules of qualification.

Responsible for review and guiding Quality Risk Managements related to Computerized Systems, Equipment qualification, Utility qualification and facility qualification.

Responsible for review, monitoring and guiding Quality Management system such are Change controls, events / deviations & CAPAs in Track wise related to CSV, Equipment qualification, Utility qualification and facility qualification.

Ensure all CAPAs related to Computerized system, Equipment qualification, Utility qualification and facility qualification are closed as per the CAPA specified time lines.

Coordination and implementation of CAPA for all internal / external audit observations related to CSV, Equipment qualification, Utility qualification and facility qualification.

Person Profile.

Education Qualification : B.Tech / M.Tech / M.Sc - Chemical Engineering / Organic Chemistry

Experience Range : 18+ years

Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.

To know more about us, Please visit our LinkedIn Page- https : / / www.linkedin.com / company / jubilantpharmova / mycompany /

Skills Required

Risk Assessment, Quality Management System, equipment qualification , Regulatory Requirements, Data Governance, Capa