Associate Director - Quality Control

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 Biosys Limited

Designation – Associate Director - Quality Control

Location- Nanjangud, Mysore

Summary

Job Summary -

Key Responsibilities.

Compliance & Documentation

• Ensure lab compliance with established procedures and regulatory standards.
• Review QC-related documents : SOPs, specifications, methods of analysis, method transfer documents.
• Ensure 21 CFR Part 11 compliance for analytical instruments (Ref : 21 CFR 211 Subpart I).
• Analytical Activities
• Oversee stability studies and holding time studies.
• Release analytical reports for raw materials, packing materials, intermediates, APIs, and in-process samples.
• Provide analytical support and technical clarifications to customers.
• Investigations & CAPA
• Lead investigations into OOT, OOS, incidents, and deviations.
• Ensure timely closure and robust implementation of CAPAs to prevent recurrence.
• Equipment & Infrastructure
• Ensure preventive maintenance and calibration of instruments.
• Participate in technical discussions for new equipment procurement.
• Approve procurement of chemicals, columns, and instrument spares.
• Regulatory & Customer Interaction
• Respond to regulatory / customer queries.
• Initiate additional studies for vendor qualification and regulatory / customer needs.
• Implement new systems / procedures in line with regulatory guidance.
• Team Management & Training
• Participate in recruitment for QC lab personnel.
• Conduct periodic training and evaluation of QC analysts.
• Participate in cross-functional investigations (product failures, complaints, deviations).
• Budgeting & Vendor Management
• Prepare and manage revenue and capital budgets for QC.
• Evaluate new vendors for lab consumables.
• Change Control
• Approve and oversee change controls and provisional process changes.
• Ensure proper documentation and closure post-implementation.

Delegation Protocol

Person Profile .

Qualification - Msc / Ph.D (Chemistry / Chemical / PCM / Bio-Chemistry)

Experience- 15+ Years of relevant experience from API industry only

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

Change Control