Company Jobs

Degree in Chemistry, Biology, or related Life Sciences. Write CMC regulatory dossiers for Drug Substance filing, small and Large API Molecules using source documents, ensuring accuracy, completeness, and compliance.

Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. 

Ensure completion of APQRs within defined timelines. Archival of the approved APQRs as applicable. Communicate with external suppliers to provide applicable approved supplier APQR and related documents to QOP.

Bachelor degree in a relevant field, such as Life Sciences or Healthcare. Proven experience in clinical data management within the pharmaceutical or biotechnology industry. ICON plc

Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting. Elanco Animal Health

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

Lead ISI Mark and CRS certification projects from application to grant. Prepare and review all documentation for BIS portal submissions. Coordinate product testing with BIS-recognized laboratories

Having sound knowledge of Operation. Troubleshooting of QC Instruments & Investigation of OOS /OOT/Deviation. (e.g HPLC, GC, UV, FTIR, Polarimeter, UV-Spectrophotometer, KF, Apparatus)

Develop, maintain, and update laboratory systems and documentation, including SOPs, IQ/OQ/PQ documents, training records, and related quality documents.