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 Biosys 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
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Jubilant Pharmova Limited
Designation -
Senior Executive - AQA
Location
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Nanjangud, Mysore
Key Responsibilities:
Shall be responsible for the following activities:
- Responsibility for analytical compliance to in-line with current regulatory guideline, monograph requirements, customer requirements and in-house procedures.
- Review the Laboratory metrics, find out the scope of improvement for laboratory compliance. Find out the scope for right first time Laboratory performance.
- Review and approval of laboratory QMS like OOS, OOT, Deviation, Change management, Incidents, Action items, CAPA, Effectiveness Check, and relative documents in through in Trackwise / SAP system, as applicable.
- Review and approval of SOP, Specification, method of Analysis, General Testing Procedure and Analytical Work Order (analytical procedures)
- Ensure the completion of QMS events as per the timelines.
- Handling of Management and Customer notification.
- Involving the customer audit and regulatory audit. To carryout internal audits, CTL audit and unscheduled audits, as and when required.
- Review and approval of instrument qualification, Method validation/Method transfer/Method verification from QC.
- To impart training on Laboratory management and also as part of CAPA implementation.
- Review of Trending of quality events and establish the CAPA to prevent recurrence.
- Review and approval of risk assessment reports.
- Ensure implementation of cross-deployed CAPA and CAPAs resulting from regulatory assessment outcome in QC chemistry and Microbiology Labs.
- Responsible for carrying out any other assignment assigned by reporting manager.
- In the absence of the position holder tactical/operational responsibilities delegated by Job description holders Manager to his direct reports.
Person Profile
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Qualification
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B. Tech. / M.Tech (Any specialization) (Chemistry/Chemical/PCM/Chemistry)
Experience-
Minimum 4+years relevant experience from API industry.
