Vadodara

Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing or fresher also apply. Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing.

The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.  Should keep the all the regulatory database up to date. Candidate must possess do it right the first-time approach with proven track record. 

Environmental monitoring  Media fill visual inspection  Aseptic area monitoring  Handling of media fill activity  Aseptic area personal qualification

Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia

Should possess Diploma, Degree in Pharmacy from a University established by law in India or its equivalent qualification. Gujarat Pharmacy Council registration is mandatory.

Experience in routine Analysis, Analytical Method Development as well as Characterization for different products of Orals, Injectables, Peptides, other dosage form and Active Pharmaceutical Ingredients

Experience in API Production, Bulk Drug, API Production To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior, Should have exposure in reactors, centrifuges, and a clean room equipped with sound knowledge in cGMP and SOPs.

To review and assess data based on Analytical QBD based approach. To ensure analytical development data supports to robust test method and suitable to entire product lifecycle.