Executive - MSTG
On-site · Dadra, Dadra and Nagar Haveli and Daman and Diu, India
Job Summary
Coordinate with multiple departments (FDD, ADD, PDD, Production, Engineering, QA/QC, Supply Chain, PM) for timely execution of new projects; plan and support execution of trial batches, scale-up/characterization batches, and process qualification batches; prepare and review documents such as material requirement sheet, master formula card, bill of materials, risk assessment reports, scale-up protocol and reports, exhibit/trial batch manufacturing records and protocols; prepare and review launch documents (material requisition sheet, product history, trial/characterization protocol and report, batch manufacturing record, process qualification protocol and reports); prepare investigation/Justification reports and regulatory evaluation materials.
Required Qualifications
- M.Pharm degree
- 2-5 years of relevant experience in regulatory affairs or related pharmaceutical functions
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