Microbiologist - Monitoring

Responsible for the sampling and analysis of environmental, water and other utility samples.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

1. Responsible for sampling of water, EM, Utilities etc.

2. Sampling during media fill in sterile manufacturing facility including plate exposure, air sampling, swab sampling, compressed air, and primary packaging component.

3. Responsible for Microbiological Environmental monitoring in microbiology and production facility.

4. Responsible for monitoring of water samples, compressed air and nitrogen gases.

5. Responsible for Media availability, Form availability etc. during Environmental monitoring.

6. Environmental Monitoring Plate observation as a doer/checker.

7. Trend Summary preparation of Environmental monitori

Responsible for the sampling and analysis of environmental, water and other utility samples.

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

1. Responsible for sampling of water, EM, Utilities etc.

2. Sampling during media fill in sterile manufacturing facility including plate exposure, air sampling, swab sampling, compressed air, and primary packaging component.

3. Responsible for Microbiological Environmental monitoring in microbiology and production facility.

4. Responsible for monitoring of water samples, compressed air and nitrogen gases.

5. Responsible for Media availability, Form availability etc. during Environmental monitoring.

6. Environmental Monitoring Plate observation as a doer/checker.

7. Trend Summary preparation of Environmental monitoring.

8. Disposal of used microbiological culture media.

9. Sampling during media fill in sterile manufacturing facility including plate exposure, air sampling, swab sampling, compressed air, and primary packaging component.

10. Ensure working area is kept clean.

11. Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements.

MININMUM EDUCATION/EXPERIENCE REQUIREMENTS

Microbiology Graduates or Equivalent

Fresh Microbiology Graduate

REQUIRED SUCCESS ATTRIBUTE

• Knowledge of GxP’s, cGMP and other regulatory requirements.

• Attention to detail

• Initiative

• Learning Agility

• Compliance

Secondary Success Attributes

• Collaboration

• Effective Communication

• Passion

Roles

Additional responsibilities can be assigned as required

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.

DELEGATION OF RESPONSIBILITY

In the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation – Strategic site responsibilities to higher level

Downward Delegation – Operational responsibilities to direct reports or similar job role