5+

This role supports drug substance and drug product development by executing characterization studies. The role involves performing and analyzing advanced analytical testing to assess critical quality attributes and support formulation development, stability studies, and regulatory submissions.

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. 

M.Sc - Microbiology / Biotechnology / B.E / B.Tech (Biotechnology), USV IS HIRING for Drug Substance Biologics Manufacturing Plant

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.

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

Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.

Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.

To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate