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 Manager Quality Control
Location- Nanjangud, Mysore
Job Context : To plan & review all the activities of the section & release the materials as per time lines by ensuring compliance. Ensuring the method transfer & method validation activities.
Challenges : To review development and operations process with preparation of SOP's and guidelines and spreading awareness of QMS.
Key Responsibilities.
Sampling and Analysis
- To ensure Sampling and analysis of RM / PM.
Records Checking
- To check the analytical records and raw data for accuracy and authenticity
SOP Preparation and Implementation
- Facilitate reviews and implementation of SOP's in the work area.
In Process QC
- Approval of specifications, STP's of RM/PM.
- Maintenance of reference standards, working standard and impurity standard, volumetric solution & Reagents.
Accident/ Incident Investigation
- Investigation of Incident & OOS in the lab.
Quality System Review
- Review of Quality system and gap analysis to meet the Regulatory requirements.
EHS
- Ensure good housekeeping and safe work practices performed by the analyst in the laboratory.
Employee Training and Development
- To guide the executives in various activities related to analysis and sampling of RM / PM.
- Responsible for training of analysts for various activities performed in the section.
- Monitoring and supervision of work performed by analyst.
Equipment Selection
- Validation of equipment and instruments.
Skills Required
Functional Skills
- Exposure to face regulatory audit like MHRA, USFDA, ANVIZA, TGA, MCC etc.
- Operating and trouble shooting skills on all analytical equipment's like HPLC, GC-HS, UV, particle size analyser etc.
- Sound knowledge on Pharmacopoeia of USP & EP is essential, Exposure to ERP system is essential preferably BaaN
Behavioural Skills
- Strong Interpersonal Skill
- Excellent Communication Skill
- Attention to detail
General Awareness : Knows the fundamental or has general understanding of concepts.
Working Knowledge : Has broad job knowledge, knows to apply the full range of concepts and practices and has broad/working knowledge of the subject. Candidate should use these concepts in day to day practices.
Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
Mastery: Candidate is subject matter expert and has command over the subject/concepts.
Person Profile.
Education Qualification: M.Sc. / M. Pharm / Ph.D. (Chemistry / Pharmaceutical Chemistry)
Experience Range : 12+ 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/