Senior Executive

Sun Pharmaceutical Industries; India; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Sun Pharmaceutical Industries in Pithampur seeks a Microbiology Analyst to join Global Quality & Compliance. You will coordinate qualification activities for microbiology lab equipment, support DQ/IQ/OQ/PQ processes, and perform environmental monitoring.

The role requires MSc in Microbiology and 8+ years of experience, with a focus on GMP, data integrity, and collaboration with QA, Production, Engineering, Validation and Project teams.

Qualifications

• Educational qualification: M. Sc. in Microbiology.
• Minimum 8+ years of relevant experience in microbiology labs.
• Experience coordinating acceptance testing and qualification activities for lab equipment.
• Familiarity with GMP, data integrity and regulatory requirements.

Responsibilities

• Coordinate installation, commissioning and qualification of microbiology lab equipment.
• Support DQ, FAT, SAT, IQ, OQ and PQ activities for equipment and utilities.
• Execute Environmental Monitoring and cleanroom qualification activities.
• Perform microbiological testing including microbial enumeration and sterility.
• Execute validation studies and method verification.
• Monitor water systems and critical utilities in the lab.
• Prepare SOPs, test methods and validation reports.
• Support APS/Media Fill and CCS implementation activities.
• Investigate deviations, CAPA, OOS/OOT and lab incidents.
• Ensure GMP documentation and data integrity in all records.

Skills

Laboratory equipment qualification

Environmental Monitoring

Microbiological testing

GMP compliance

Data Integrity

Education

M. Sc. in Microbiology

Job description

Job Title:

Microbiology Analyst

Business Unit:

Global Quality & Compliance

Job Grade

G11B

Location :

Pithampur

Responsibilities

1. Coordinate installation, commissioning and qualification of microbiology laboratory equipment.
2. Participate in DQ, FAT, SAT, IQ, OQ and PQ activities for microbiology equipment, cleanrooms, HVAC, LAF/BSC, autoclaves, incubators and utilities.
3. Execute Environmental Monitoring (EM) and cleanroom qualification activities, including data review, trending and investigation of excursions.
4. Perform/review microbiological testing including Microbial Enumeration, Microbiological Assay, Sterility, BET, Bioburden, Water and Environmental Monitoring.
5. Execute microbiological method verification, validation and method suitability studies.
6. Execute qualification and microbiological monitoring of water systems and critical utilities
7. Preparation of SOPs, Specifications, Standard Test procedures, QRM, Validation protocols & summary reports.
8. Execute disinfectant efficacy studies and Execute cleaning/disinfection validation activities.
9. Participate in Aseptic Process Simulation (APS)/Media Fill, including execution, monitoring, incubation and documentation.
10. Execute implementation of the Contamination Control Strategy (CCS) and associated microbiological risk assessments.
11. Handle/investigate Deviation, Change Control, CAPA, OOS/OOT and laboratory incidents.
12. Prepare SOPs, Specifications, STPs, QRM, qualification/validation protocols and reports.
13. Ensure laboratory documentation complies with GMP and Data Integrity requirements.
14. Execute greenfield project commissioning, microbiology laboratory setup and operational readiness.
15. Coordinate daily laboratory activities and provide technical guidance/training to junior team members.
16. Coordinate with QA, Production, Engineering, Validation and Project teams to ensure timely completion of assigned activities.
17. Maintain working knowledge of USP, EP, JP, WHO GMP, PIC/S, EU GMP Annex 1, 21 CFR 210/211, ISO 14644, Data Integrity and PDA guidance.

Travel Estimate

NA

Job Requirements

Education Qualification

M. Sc. In Microbiology

Experience

Tenure: 8+ 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).