Job Description

Exposure of product development related activities of all injectable dosage forms for regulated market (General injectable, Onco, Peptide products) Understanding of ANDA and 505b2 product filing. Exposure to wide range of dosage form (liquid solution, lyophilized, suspension etc.) Understanding of Drug device combination products and regulatory expectations. Experienced in preparation and review of product development report, MFR, stability protocol, other study protocols, SOP etc. Basic understanding of implementation of QbD principles for formulation development (QTTP, CQA, CPP, CMA, Risk assessment and Control strategy etc.) Effective co-ordination with different department like regulatory affairs, manufacturing, warehouse, quality assurance, quality control and engineering etc. for execution of scale-up, exhibit batches etc. Exposure of various QMS documents like change control, planned deviation, unplanned deviation etc. Exposure of API specification, DMF, Excipients specification, In-process specification, Finished product & Shelf-life specification of injectable products. Exposure of preparation and review of necessary documents required for ANDA submission and query response of products.

Minimum M Pharm



Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.