Good knowledge in monitoring compliance by GSK and Third Parties with PVASC by carrying out routine reconciliations and compliance checks and communicating standard information to Third Parties as required with appropriate guidance.
Masters degree in Life Sciences or equivalence scientific degree with minimum of 5-7 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven leadership, technical specialist role experience in health authority interactions
Prepare and review the responses to Health Canada requeue and Deficiency Letters in timely manner to ensure prompt regulatory approvals of dossiers under supervision of Deputy Manager.
M.Sc. / M Pharm / PhD. Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
B.Pharma/ MSc Chemistry; Candidate should have knowledge of packing operations. Knowledge of BQS, Autocarnator and Bottle packing. Responsible to adherence cGMP guidelines.
etermine biocompatibility testing required to demonstrate product safety. Document risk assessments in Baxter qualified systems such as Team Center Unified, Trackwise 8, Electronic Laboratory Notebook. Generate protocols and reports for biocompatibility testing.