5+

Candidate acquainted of Quality Management System Document like Change control, Deviation and their Investigations, CAPA and Audit Management. This role will focus on ensuring the highest standards of quality throughout the manufacturing process, specifically for active pharmaceutical ingredients

Support the Quality vision and mission for Amgen India aligned with Amgen’s mission to serve patients. Support Amgen India Quality Team Lead in the development and implementation of a multi-year Quality technological plan aligned with Amgens standards and overall strategic imperatives.

HPLC, GC, IR, UV, Dissolution and other QC Equipment, QC Method Validation and Transfer.

Exposure to aseptic process activities, aseptic techniques, aseptic filling and sealing activities, and media filling activities. Experience in operating autoclaves and terminal sterilizers. Preparation of autoclave loads, loading and unloading of autoclaves and sterilizers

Define and implement the formulation development strategy, aligning with the broader RAD and business objectives. Lead the preparation of development reports, protocols, and documentation required for regulatory submissions. Identify and implement cutting-edge formulation technologies for new drug delivery systems. Ph.D / M.Pharm, Formulation Development NCE, Medicinal Chemistry

M.Sc / B.Pharm / M.Pharm; Computerized System Validation CSV, MES, Equipment Qualification; RM/PM, Dispensing, Inspection

B.Pharmacy / M.Pharmacy; Candidate should have Injectable experience and sound knowledge on manufacturing and packing activities of liquid and Lyo products. Aseptic process simulation, process validation, cleaning validation, Batch records review and batch release.

Knowledge of FDA, cGMP, ICH, DMF guidelines for regulatory submissions. Hands on experience in CMC submissions, supplemental applications. Experience working on labels will have added advantage. Excellent written and verbal communication skills; experience in Regulatory Affairs of Finished dosage formulations mainly for USFDA, EU. M Pharmacy / M. Sc. / B Pharm

M.Pharm / B.Pharm / M. tech / B. tech / B.E. / B.sc / Diploma / ITI; Tablet, Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. HPLC, GC, IR, UV, Dissolution and other QC Equipment, QC Method Validation and Transfer.