Amneal

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.

Supervise and execute manufacturing activities in Granulation, Coating, Compression, and Capsulation as per cGMP and approved SOPs; Operate and monitor manufacturing equipment, ensuring proper batch setting, material handling, cleaning, and equipment performance, Amneal Pharmaceuticals

Perform analysis of raw materials and in-process/finished products using : UV, IR, HPLC, UPLC, GC, LCMS etc. 

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

Hands-on experience in Bag Filling Machine, preferably SHINVA Bag Filling / PLUMAT. Handling complex manufacturing processes such as Emulsion and Suspension.

Looking for candidates with relevant experience in injectable regulated plant. Virtual Walk in for Pharma and Science candidates in Production, Packing, Warehouse at Amneal Pharma