Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.
Responsible for the design, planning, operation and monitoring of the downstream group and this for development activities as well as for scale-up and GMP production
Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met. Review, compile and dispatch new product submissions and pre-launch variations.
BA / BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS / PhD /PharmD ) with at least 2 years clinical trial experience.
looking for a meticulous professional to lead drug product manufacturing and sterile formulation operations, ensuring adherence to Current Good Manufacturing Practice, cGMP and safety norms.
B.Pharm / MSc; To perform the calibration of QC instruments as per calibration schedule. Overall upkeep of respective working bench as well as of the section as per GLP.
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects. Amneal Pharmaceuticals. Qualification : B.Pharm, M.Pharm