Experience in handling equipment like Reactor, Centrifuge, ANFD, Multimill, Micronisation, Sparkler filters, Technology Transfer for scale up at Pilot Plant. Handled finished goods store, Dispatch, Export, Domestic Knowledge of E-Way Bill, customs, GST.
Regulated markets and currently working as a shift incharge. Experience in compression, granulation and should possess expertise in Quality Management System (QMS) production.
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Sterile manufacturing Suspension/emulsion /PFS / BFS as well as SKID operation. Should have experience in Aseptic process, complex manufacturing, Exposure to CIP/ SIP SKID, QMS.
Executing chemical reactions to synthesize required quantities of molecules/ compounds as per client specifications using efficient route and techniques.
Exposure to analytical method development and validation Raw material, Intermediate and Formulated Finished Products from natural sources. Exposure to HPLC, HPTLC, GC MS/MS, LCMS, FTIR and other analytical instruments along with Physical and Chemical analysis as per IP, USP, AOAC, API etc
Compile registration dossiers for submission to various health authorities like – USA, Canada, Europe, Australia and Israel. Prepare responses to deficiency letters received from various agencies.
For all the positions, it is essential for candidates to have exposure in Injectable Sterile plant and regulatory requirements of documentation as per cGMP/GLP.