F&D

Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.

Lab Exposure, Analytical Method Validation. Review of Specification. Method of Analysis Protocol Handing of 00S and 00T. Investigation and Lab event. Review & Approval of QC Documents. Knowledge of Qualification and Validation related Activities. Audit Trail Review etc 

Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development. Submission of documents and coordination with liaison personnel for procuring required licenses for carrying out the development work. M.Pharm or Ph.D. in Pharmacy with minimum industrial experience

Plan, implement and evaluate experiments for establishing of composition, manufacturing procedures and packaging via support of def. evaluation experiments taking product stability, bioequivalence and possible production site into consideration.

Conduct literature survey and compile the scientific findings for allocated projects. Plan and perform the Pre-formulation studies, and innovator product characterization.

Knowledge of regulatory guidelines applicable to formulation development. Must have handled ER, MR, Pellets drug products for US and EU market.

PhD Pharmaceutical Sciences, Chemistry, Biochemistry a relevant branch of Engineering Industrial Experience min. 1 year in Formulation department of any Pharmaceutical company

Must have experience in the development of nasal spray, nebuliser and other respiratory dosage form. Exposure of regulated and domestic product development

Investigation Tools, 5Y, Fish Bond, 6M, QMS Activities, Change Control, Deviations, CAPA, Monthly MIS Data. IPQA - OSD and lnjectable, AQA, QA Stability, APQR, Documentation, Validation, QMS, CQA, Artwork