Lab Exposure, Analytical Method Validation. Review of Specification. Method of Analysis Protocol Handing of 00S and 00T. Investigation and Lab event. Review & Approval of QC Documents. Knowledge of Qualification and Validation related Activities. Audit Trail Review etc
Experience in pharmacovigilance, in clinical care, or in clinical or scientific research is an advantage but not a requirement. Demonstrated computer literacy, particularly in the use and management of relational databases.
Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches and reviewing GMP related documents.
M.Pharm, B.Pharm, M.Sc, B.Sc, ITI, Diploma ; 2-6 years of experience in operating of Granulation, Compression, Bulk line, Auto-Cartonator and Blister Elmach 3015 Packing
Fresenius Kabi India is a global healthcare company MNC) that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically & chronically ill patients.
Having experience in Injectable - IQ, OQ, PQ of process equipment,utilities, lab equipment and Instrument, Sops, Protocal preparation,execution, Compilation and report prepartion.
Hands on Experience in IPQA Manufacturing process and Engineering IPQA, AQA Micro, Documentation, Validations, Stability Management and Document review.