Jubilant Generics Limited (Formerly Jubilant Life Sciences) is an integrated Pharmaceutical company Life Sciences company. As India’s largest Custom Research and Manufacturing Services (CRAMS) player and a leading Drug Discovery and Development Solutions provider out of India, it is constantly engaged in delivering value to its global customers through innovative technologies, products and services
Job Title – Research Associate
Summary – Responsible for smooth functioning of Regulatory Affairs function at site.
- Review of station wise stability data/Stability compilation sheet of ongoing products as well as exhibit batches & Stability protocol for adequacy.
- Review of laboratory Equipment/Instrument usage log book as well as preventive maintenance /breakdown logbook & ensure GLP Compliance (data integrity)
- Handling of DRA queries related to document submitted for filling.
- Review of Investigation report
- Review of Finished product analytical document of commercial supply & DPDM as per regulatory requirement.
- Review of STP/Specification & SOP/ GTP with respect to pharmacopeial as well as regulatory requirement.
- Review of BMR/BPR of exhibit as well as commercial for adequacy.
Qualifications & Experience:
- B Pharma/ M Pharma with 4-5 years of experience in Operations of Pharma unit with strong exposure to all regulatory requirements.
- Good knowledge of Regulatory guidelines such as USFDA, MHRA, TGA, ANVISA etc.,
- Good Analytical Skills