Strong knowledge of GMP, GDP, and regulatory compliance for pharmaceutical warehousing. Exposure of various instruments/ software like empower 3, LIMS and other software.
Candidate should be well versed with operation and maintenance of ointment manufacturing plant and handling PLC, SCADA. Handling of tube filling activity and packing activity of ointment, creams, lotions.
Exposure to OSD Manufacturing operations like Granulation, Compression, Pellet coaling, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will he added advantage. Experience of HPLC, UV spectrophotometer and Dissolution Tester operation. Experience of Analytical Method Validation/Transfer. Experience of GC, ICPMS and/or LCMS operation.
Redaction of clinical trial documents in accordance with evolving global regulations. Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation and other regulations. Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information, PRCI, EU Clinical Trial Regulation, and other global regulations.
Support Analytical project leader for setting analytical development strategy. Support in data interpretation, results compilations and sharing the information with critical observations and proposals to project team.
Established in 1991, Lactose India Limited is a young and innovative company specializing in the manufacturing of Excipients Lactose, Colour Coatings, Lactulose, Solid Dosage Forms, Liquid Dosage Forms, at Vadodara, Gujarat.
Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
Hands on Experience for handling critical lab instruments like HPLC, GC, Dissolution, UV Spectrophotometer, LIMS, FTIR , experience in Analysis of RM, FP and IP stability in QC.
Candidate must have 2-7 years of experience in production, including operations and supervision of autoclave processes terminal sterilization and components, filter integrity testing, aseptic and controlled area operations, as well as proficiency in vial washing and filling machine operations.