• Responsible for microbiological activities in the plant with respect to testing of component, raw material, packaging material, in process and finished products and environment monitoring
• Support continuous compliance to local and statutory microbiological requirement with respect to ISO, CE, India FDA
• Maintenance of good housekeeping, safe and correct use of micro lab equipment
• Maintenance of control samples and records
• Support sterilization validation w.r.t microbiological testing
• Liaison with external laboratory for testing
• Liaison with production dept. for sample collection if any request arise from Spain
• Shall conduct verification study in order to improve hygiene system especially in clean room
• Train the people in GMP to improve overall quality
• Support QC in incoming material release and documentation
• Responsible to support implementing Occupational Health and Safety (OHS) management systems, processes and procedures that improves the Occupational Health and Safety of the employees and other interested parties in according to ISO 45001
• Responsible to support implementation of Environment management systems, processes and procedures in accordance with ISO 14001
• Monitoring & analysis of sterilized products

KRAs & Specific Roles:

• To ensure timely Microbiology testing and release of incoming materials, finished material as per specification
• To ensure adequate set up of micro lab and related equipments and train Laboratory Personnel
• To ensure Testing of finished products as per specification and approve / Reject the finished goods and forward all batch reports to QA for approval
• TO review Laboratory & calibration Procedures and complete calibrations as per requirements
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• Responsible for monitoring & testing of sterile products & retention sample
• Responsible for investigation of deviation / Non conformance reports and customer complaints
• Support sterilization validation w.r.t Microbiological testing
• Maintenance of quality records and proper documentation
• Make optimal utilization of resources within the given environment and work
• The position should be able to support & co-ordinate with all functions for testing & analysis
• The position should be well versed in microbiological testing & analysis have knowledge of material & products
• The position should have good communication & intern-personnel skills to interact with various functions in order to co-ordinate the activities
• The position should have the skills on learning & applying, customer orientation and be able to work in teams