This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory.
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.
To handle all kind of lab instruments and experience to perform AMV and Documentation
EM Monitoring, Water testing. Trend preparation, Microbial Testing, SOP and Protocol and other micro related activity
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.
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.