Shop floor - Microbiology

Job Title:

Shop floor (Microbiology)

Business Unit:

Global Quality & Compliance

Job Grade

DGM

Location :

Halol

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

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.”

Key responsibilities:

1. Planning and monitoring of environmental monitoring within facility.

• Evaluation and interpretation of environmental monitoring VPC, NVPC and utility monitoring (nitrogen gas, compressed air, CO2 gas) results.


• Oversight of the aseptic operations, environmental monitoring activity – for viable particle count (VPC) and Non-Viable particle count (NVPC).


• To review trend for viable and non-viable monitoring data and suggest action if any.


• To review trend of microbiological monitoring of personnel of aseptic area. To participate in the aseptic process risk assessment.


• To participate in evaluating the sampling locations for environmental monitoring based on risk assessment and critical interventions.


• Planning and monitoring to maintain all environmental monitoring related all systems.


• To review smoke study protocol and executed videos.

2. Handling of Environmental monitoring (Viable and non-viable) related incident.

• To review the incident related to aseptic practices.


• Participate in the microbiological related incidents, investigation and other microbial impact assessment wherever and whenever required.

3. Planning and monitoring to media fill related activities

• Handling of media fill visual inspection activity and media fill video review and summary preparation.


• To participate in media fill process. Evaluate the protocol for interventions to be performed and review of media fill related documentation.


• To monitor clean room practices during routine production and media fill runs to evaluate and to suggest improvement in practices if required.


• Participate in the investigations media fill investigations.

4. Sterility assurance:

• Responsible for the Aseptic core monitoring evaluation and compilation of sterility assurance review board data.


• Conducting the sterility assurance review board and implementing the actions are derived from sterility assurance review board.


• Involve implementation of contamination control strategy (CCS) across all the blocks and CCS assessment report review.

5. ACT as system owner and ensure computerized system are validated for its intended use through its lifecycle.

6. Ensure the computerized systems validated in compliance with the quality policies, standards and procedures and are maintained in validated statue throughout the lifecycle.

7. Planning and monitoring for training of the analysts and newly joined employee

8. Planning and monitoring for pharmacopeia changes updating

9. Planning and monitoring for preparation and reviewing of documents

10. CAPEX approval and annual budgeting

11. Timely response to audit compliance.

12. To fulfil the regulatory requirements.

13. Support the assessment and remediation of identified activities as part of various corporate initiatives.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc - Microbiology

Experience

20 + years   

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!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).