M.Pharm

Supports to the Laboratory functions to handle Investigations, Deviation Management, Specifications ,test methods, method validations equipment qualifications ,internal audits and escalations if any.

Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. 

Experience in solid oral dosage & liquid orals form in formulation & development department for regulated market

Equipment qualification - Autoclave qualification, vial washing machine qualification, tunnel qualification, filling machine qualification, UAF, Mobile cart & DPB qualification.

Exposure of Handling Production, Manufacturing Area, Production QMS Investigation. Exposure of Process Plant Maintenance.

Required Qualifications MPharm, BPharm, MSc (Chemistry, Biotechnology, Life Science), BSc in Manufacturing

B.Pharm, Pharm.D or equivalent with two years post-qualification experience in clinical project management and/or clinical trial/ study monitoring in a recognised organisation / institute

M.Pharma in Pharmaceutics or M.Tech in Biotechnology. GPAT is desirable but not mandatory Working Experience in the area of advanced drug delivery systems, cancer, bacterial study, protein purification, and recombinant DNA technology using plasmid vectors is desirable. 

Post - Graduation in any discipline of life sciences from a Govt. recognized University or Institute with at least 60% marks in aggregate or equivalent grade for general category candidates.