Having Experience in Environmental Monitoring, Water Testing, In process Sampling, Analysis of Bulk Water, Finished and API by MLT, Bioburden, BET, Sterility, PET and Antibiotic Assay.
B.Pharm / M.Pharm; To perform equipment qualification, utility qualification activity with proper documentations. To perform Computer system validation. To investigate deviation, change request, OOS, market complaint etc.
Create and review regulatory documentation for Drug, Device and Combination product renewals and other life cycle maintenance-related submissions. Track status and progress of regulatory documentation.
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.
Execute the Formulation Technology Transfer activities across all Cipla sites and CMO to standardize, strengthen and improve the technology transfer processes and systems in line with regulations
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.
Chemical structure database query and extensive knowledge of structure elucidation of isolated molecules. Effective contribution to discover, isolate, and characterize novel classes of bioactives, secondary metabolites from targeted microbial resources.