5+

Bachelors in life science/healthcare required; Advanced degree or equivalent education / degree in life sciences / healthcare preferred (PhD/MD/PharmD/ Masters).

Analysis of RM-PM or IP-FP and handling of HPLC (Waters and SHIMADZU), GC(Agilent) is must

Preparation and updation of SOPs, BMRs, Log books, protocols and compliance thereof with training of people on the same.  Handling and monitoring of Environmental monitoring systemsystem.

This is a high-impact leadership opportunity to shape and drive enterprise-wide project governance across R&D and Manufacturing. Strong exposure to R&D, Drug Substance & Drug Product Manufacturing projects in Biologies Proven expertise in Program / Portfolio Management.

Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.

Regulatory Affairs experience in the US and Canadian markets, with expertise in OSD and Injectable submissions, strong knowledge of AN DA and eCTD, proven team handling and leadership skills, and regulatory exposure to both.

Manage procurement of raw materials, solvents, and intermediates. Coordinate with suppliers to ensure timely material availability. Monitor inventory, purchase orders, and procurement documentation.

Having good experience and exposure in Granulation (ACG, Glatt, GEA ), Coating (Preference to Enteric & Sugar Coating), and Compression (Kilian & Fette Machines), Packing (CVC Blister Packing & Blister Cartonator), Documentation (SOP Revision ,QMS