Head Microbiology

Title:

Head - Microbiology

Business Unit:

SGO Quality

Job Grade

Senior Manager

Location:

Mohali

Key Responsibilities

Create your own sunshine

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Oversight and Monitoring of Microbiology Laboratory

1. Provide leadership and direction to ensure achievement of all Quality, Microbiological goals.
2. Organize

   Microbiological testing and release of different type of samples

   i.e. raw materials, finished product, commercial stability, Exhibit stability, miscellaneous samples.
3. Organize Microbiological testing and release of Raw / Potable/ Purified water samples.
4. 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.
5. Organize handling & Maintenance of microbial cultures. Isolation and identification of microbial isolates from various sources. Ensure effective system for maintaining microbial cultures.
6. 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.
7. Participate in external and/or regulatory inspections of Microbiology operations at the site.
8. Ensure preparation of trend and annual summary reports of Raw/Potable/Purified water/Microbial environmental monitoring/Microbial isolates etc.
9. Ensure consistency in Microbiology lab operations and drive continuous improvements in laboratory performance.
10. Ensure compliance to cGMP/GLP and applicable safety standards in the Microbiology laboratory.
11. Accountable for all product compliance related activities being performed in the Quality Control Microbiology Laboratory.

12. Responsible for imparting training to employees as a qualified trainer.

13. Determine and make available resources (staff, instruments, training, lab space, etc.) in microbiology function at the site.
14. Responsible to perform the internal audit as per the site specific procedures.
15. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence.
16. Performs all work in accordance with all established regulatory and compliance and safety requirements          
17.  Review log books, Instrument calibration records, Instrument Periodic performance records, data summary reports and certificate of analysis for accuracy and completeness.
18. Any other activities assigned by Site Quality Head.

Travel Estimate

Low

Job Requirements

Educational Qualification

M. Sc Microbiology

Experience

15 to 20 Years with USFDA plant experience is mandatory

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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