Amneal

This role is responsible for developing and optimizing pharmaceutical packaging systems by applying scientific and engineering principles to ensure product protection, stability, compliance, and patient usability.

Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.

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.

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

Responsible for preparation and review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. 

Looking for Aseptic and Packing Operators in Manufacturing for our Injectable facility at SEZ Matoda regulated plant

Bachelor or Master Degree -MS/MA- Science Field. Support protocol amendments, Investigators Brochure updates, and Informed Consent Form revisions. Maintain Trial Master File, TMF and ensure timely filing and quality control of essential documents

Supervisor is responsible for preparation, review, revision, control and implementation of standard operating procedures activity, Change control and CAPA of Sterile manufacturing department

Ensure qualification documentation complies with GMP and regulatory requirements. Knowledge of GAMP 5 and 21 CFR Part 11. Strong Understanding of ALCOA principles.