Skill on lead generation and tapping new business opportunities from innovators. Extensive exposure to Business Development, Budgeting and Business Planning.
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.
Perform all the labelling update activities and tracking in systems for record maintenance with respect to New Product Development NPD label creation and Product Life Cycle Management PLCM update for products in USA and Canada market
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.
Candidates with experience in handling of sophisticated instruments e.g. HPLC, GC, UV, IR, Dissolution apparatuses and other laboratory equipment are preferred.