Gujarat

Define, organize, plan and execute analytical activities and materials characterization of pharmaceutical injectables in compliance with current international/regional/national regulations with the support of senior colleagues and team members.

B.Pharm / M.Pharm; Preparation of responses to clarification requests received from Canadian authorities. Communicate with external suppliers for the preparation of packaging components and ensure technical feasibility.

Should have detailed knowledge as well as experience of working for an injectable manufacturing process. Should have compendia and regulatory knowledge of aseptic processing and controls and Contamination control strategy program.

OSD, Oncology and Cosmeceutical (Sunscreen, Anti Acne, Moisturizer, De-pigmentation, Baby products and soaps). Exposure of Regulated, Semi Regulated & India Markets.

Environmental monitoring of manufacturing clean room area. Non-viable particle monitoring of manufacturing clean room area. Personnel monitoring. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc.

Exposure of QMS activities Exposure of Ampho, Bupivacaine Autoclave Operation and Supervision Lyo Operation and Supervision Regulatory Audit exposure Online documentation of BMR and log books during execution of batches

D.Pharm, B.Pharm, M.Pharm with Gujarat State Pharmacy Council Drug License.

The candidate should have qualified GPAT, GATE, NET, any other National Fellowship valid score card. In addition to the above-mentioned, subject-wise qualifying degree with a minimum of 60% marks in aggregate or CGPA of 6.75 on a 10-point scale wherever grades are awarded or equivalent.

Environmental monitoring of manufacturing clean room area. Non-viable particle monitoring of manufacturing clean room area. Personnel monitoring.