DEPARTMENT & SUB AREA : Quality and Microbiology
ACADEMIC QUALIFICATION : Minimum M.Sc. Microbiology
TOTAL EXPERIENCE : Minimum 20 + Years
Job Summary :
Responsible for Oversight and Monitoring of Microbiology Laboratory at the site. This position shall be responsible to assure Microbiological quality of products manufactured at site and distributed to global markets.
Essential Job Functions:
- Provide leadership and direction to ensure achievement of all Quality, Microbiological goals.
- 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.
