Amneal Pharmaceuatical

Required Experience of: Receipt, storage and dispensing of Raw Material & Packaging Materials as per their respective Sops. Online documentation for all transactions of materials and all activities wh

Description: To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site To work as key core team member for LIMS activities. Pre

Key Responsibilities Develop and apply population PK and PK/PD (exposure–response) models to inform dose selection, optimization, and trial design (NONMEM, Monolix, or nlmixr2; R for data processing,

Job Description: Scientific review of Protocol and related documents i.e ICF, CRF, Plans, logs and forms, etc. as per regulatory requirements. Review of SIV presentations prepared by CRO and check for

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.

The ideal candidate should possess strong hands-on expertise in mammalian cell culture, molecular and cellular assays, gene/protein expression studies, mechanistic biology, and advanced in vitro model

Description: Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. API DMF and DMF Change Notification review with respect to USFDA regulatory

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / top

Maintain and follow the procedure as per SOP in day to day activity of warehouse. Receipt of materials, Physical verification and Preparation of Good Receipt Note in ERP systems and mail to concern us

Description: To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitor