Gujarat

Ensure compliance of online documentation and line clearance activities. Review and approve executed BMRs/BPRs, logbooks, and related records.

Masters degree in Biotechnology/Biochemistry/Microbiology Bioinformatics/ Biotechnology/ Life science/Biomedical Sciences/Bio-Engineering passed with minimum 55% marks.

B.Pharm, M.Sc, B.Sc, ITI, Diploma, Pharmaceuticals Experience Only & Preferable Male Candidate Only

Life Cycle management of branded portfolio from IP perspective including competition tracking. IP support for out-licensing projects.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

Strong knowledge of GMP regulations including WHO, EU GMP, PICS, TGA, MHRA, USFDA & other global regulatory guidlines. Expertise in handling CAPA, CCF, deviations, market complaints, product recalls if any.

Preparation & review of New and Existing Products artwork. Responsible to maintained artworks track records in excel.

To perform the role & responsibilities defined as per TMS software. Escalation to Superior for major non- conformities timely.

Assist in the preparation of response packages to Health Canada requests in a timely manner to minimize delays in the submission review process.