Asst Manager / Deputy Manager, Formulation & Development Injectable

• Exposure of product development related activities of all injectable dosage forms for regulated market (General injectable, Onco, Peptide products)
• Understanding of ANDA and 505b2 product filing.
• Exposure to wide range of dosage form (liquid solution, lyophilized, suspension etc.)
• Understanding of Drug device combination products and regulatory expectations.
• Experienced in preparation and review of product development report, MFR, stability protocol, other study protocols, SOP etc.
• Basic understanding of implementation of QbD principles for formulation development (QTTP, CQA, CPP, CMA, Risk assessment and Control strategy etc.)
• Effective co-ordination with different department like regulatory affairs, manufacturing, warehouse, quality assurance, quality control and engineering etc. for execution of scale-up, exhibit batches etc.
• Exposure of various QMS documents like change control, planned deviation, unplanned deviation etc.
• Exposure of API specification, DMF, Excipients specification, In-process specification, Finished product & Shelf-life specification of injectable products.
• Exposure of preparation and review of necessary documents required for ANDA submission and query response of products.

Minimum M Pharm