Site Microbiology Head
Sun Pharmaceutical Industries
- Mohali, Punjab
- Permanent
- Full-time
- Organize Microbiological testing and release of different type of samples i.e. raw materials, finished product, commercial stability, Exhibit stability, miscellaneous samples.
- Organize Microbiological testing and release of Raw / Potable / Purified water samples.
- Organize Microbial Environmental Monitoring of passive air/active air/ compressed air/equipment surfaces /personnel monitoring & drain points of manufacturing associated environment of Manufacturing blocks, ware houses & Microbiology lab.
- Organize handling & maintenance of microbial cultures. Isolation and identification of microbial isolates from various sources. Ensure effective system for maintaining microbial cultures.
- Participate in the investigation of out-of-Specification results, out of trends results, conduct investigation for root cause analysis/corrective actions and systems to ensure compliance to quality requirement. Handling of Change control and CAPA management.
- Participate in external and/or regulatory inspections of Microbiology operations at the site.
- Ensure preparation of trend and annual summary reports of Raw/Potable/Purified water/Microbial environmental monitoring/Microbial isolates etc.
- Ensure consistency in Microbiology lab operations and drive continuous improvements in laboratory performance.
- Ensure compliance to cGMP/GLP and applicable safety standards in the Microbiology laboratory.
- Accountable for all product compliance related activities being performed in the Quality Control Microbiology Laboratory.
- Responsible for imparting training to employees as a qualified trainer.
- Determine and make available resources (staff, instruments, training, lab space, etc.) in microbiology function at the site.
- Responsible to perform the internal audit as per the site specific procedures.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence.
- Performs all work in accordance with all established regulatory and compliance and safety requirements
- Review log books, Instrument calibration records, Instrument Periodic performance records, data summary reports and certificate of analysis for accuracy and completeness.
- Any other activities assigned by Quality Head.