Handling end-to-end project management activities for new product launches for all Regulated and semi regulated markets for first launch. Handling Life cycle management and CMO projects.
To perform line clearance activity before starting of different operations like dispensing, manufacturing, filling, inspection, sealing, labeling & packing.
M.Sc, M.Pharma, B.Pharma. Working in QC analyzing, Stability. In process. FP. RM sample. Handling instruments like HPLC. GC. FTIR. UV, DR. SSA. etc. versatile In handling SAP. documentation like preparing STPs and review of analytical hard copies and electronic data.
Granulation, Coating, Compression, Bottle Packing Machine Exposure, RMG, FBE, FETTE, Autocoaters /Bottle Packing line with track and trace system. To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.
Looking to hire Head Of Regulatory Affairs - an aggressive, dynamic Regulatory Affairs Professional. Who would assume the Regulatory strategic, filing and post approval life cycle management and Quality, Technical and regulatory compliance responsibilities as per EU, UK, USA, and PIC, s requirements.
Experience in API Production, Bulk Drug, API Production To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior, Should have exposure in reactors, centrifuges, and a clean room equipped with sound knowledge in cGMP and SOPs.
Expertise in Injectables, Biosimilars as primary requirement and experience in handling Oral dosage forms as additional requirement. Support business decision makers in terms of resource allocation, risk management, collaboration, and prioritization. Operational technical support to ensure product reliability, support portfolio growth, cost improvement by optimize.