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 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 : Director / Senior Director - Quality Department
Reporting : Reports to Head Global Quality; Matrix reporting to CEO & MD / COO (as applicable)
Location : Nanjangud, Mysore
Proficiencies Required:
- Extensive experience of Sustainable Compliance of a cGMP site
- Regulatory inspection management experience with U.S. FDA, Health Canada and EU inspections
- Experience building a strong Quality Culture
- Maintaining the site in an ongoing inspection readiness state
- Ability to present issues and solutions to the site and corporate management teams.
- Expertise in Cross-containment control
- Experience in building a team that includes the mindset that the Quality of the products must come first
- Investigation resolution
- Quality metrics management (compliance & productivity)
- Equipment & facility cleaning management and validation
- Product failure investigations
- Electronic data governance
- Regulatory response writing and CAPA management
- Conflict management
- Strong Data analysis and decision-making
- Experience of modernization of processes and methods
Key Responsibilities.
- Maintain the site in a compliant state that is inspection ready at all times
- Sets Quality related KRAs for the GMP site in collaboration with site management
- Designs, approves, implements and maintains the quality management system;
- Ensures that the necessary human and material resources, as well as the necessary information, are available to enable effective operation and control of the processes of the quality management system and manage quality Budget effectively
- Assesses the facilities, procedures, practices, and training of personnel in regard to the quality management system;
- Collaborates well to solve issues, improve compliance and promote a strong Quality Culture for the site;
- Establishes an internal audit program and facitilate all time audit readiness
- Ensures that the quality management system is managed and maintained;
- Establishes and monitors all processes and procedures for the quality management system;
- Resolves nonconformities;
- Ensures that action is taken in order to obtain continuous improvement of processes/activities;
- Ensures all staff has up-to-date QMS training.
- Ensure all staff (QC and QA) has required technical competency and capability and assess the competency of all site in terms of GMP knowledge
- Reports on Quality status through periodic Quality Council meetings with the site and Corporate teams.
Person Profile.
Qualification- M.Sc / M.Pharm / B.Tech – Chemical or related field
Experience:
- 18+ Years of relevant experience along with minimum 5–7 years of experience working as Head Quality
- Experience in leading quality organizations of 250 personnel
- Strong exposure to Manufacturing, Quality Control (QC) and/or Technical Services (TSD) preferred
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/
