- Responsible for maintaining the lab compliance with regulatory requirements and procedures.
- Preparation and review of SOP’s, Protocols, test methods and reports.
- Preparation of method validation protocol and execution as per protocol
- Planning of day-to-day activities of Microbial analysis of finished products, water samples, air monitoring.
- Procurement and maintenance of media, chemicals and Instrumental spares of Microbiology laboratory.
- Maintenance of mother cultures / readymade culture, periodic subcultures, destruction of obsolete cultures and maintain records of the same.
- Preparation and review of trend charts for water and environment monitoring results and for communication to the respective department for required action.
- Ensuring qualification, calibration of equipment as per schedule and approved procedure.
- Review and approval of microbial analytical test reports.
- Training (on the job) to recent and existing employees.
- Responsible for co-ordination of department learning management system activities through compliance wire (CW).
- Responsible for QC - Microbiology change management
- Responsible for QC - Microbiology CAPA implementation
- To conduct OOS, Incident and Deviation investigations of microbial test results and failure investigations
- Any other activity assigned by manager
.Person Profile.
Education Qualification: Degree in Science/ Post Graduate in Science (Chemistry)/ Bachelor of Pharmacy/ Master in Pharmacy and Doctorate
Experience Range: 15+ years in API industry
Long Description
Long Description
Long Description
Skills
📌 Senior Manager-Quality Control (Karnataka)
🏢 Jubilant Biosys
📍 Karnataka
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