Qa Microbiologist

Role & responsibilities

• Planning of In-Process, Finished products, Stability Samples, Swabs, Packing Materials, Environmental Monitoring, Water Analysis and Miscellaneous Samples.
• Preparation and review of MLT reports.
• Review of analytical records and raw data.
• Adherence of SOPs, STPs and GTPs.
• Investigation of Lab incidents, Out of Specification, Deviation and Out of Trend Results.
• Training and development of analyst. Timely completion of all trainings assignment in
• the compliance wire.
• Preparation and Review of Specification, Standard Test Procedure, GTPs, Record of Analysis for Raw Material, Packing Material, Finished Product and all types of protocol.
• Qualification and Re-Qualification of instruments and Equipments, any other validation activities.
• Indent for General items required in Microbiology Laboratory
• Management of Outside Samples.
• Ensuring of CGMP, and data integrity in Microbiology Laboratory.
• Track Wise handling of Deviation, Change Control, CAPA, OOT, OOS etc.
• Review and Approve the documents in SAP and EDMS software.

Preferred candidate profile