Lead Microbiology

Job Title:

Head Microbiology

Business Unit:

Global Quality and Compliance

Job Grade

Senior Manager

Location :

Mohali

Responsibilities

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.

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.

1. Coordinate equipment procurement, technical evaluation, installation and qualification.
2. Participate in design review, risk assessment, constructability review and GMP review from a Microbiological perspective.
3. Participate in DQ, FAT, SAT, IQ, OQ and PQ activities for systems impacting microbiological quality.
4. Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
5. Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
6. Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
7. Prepare SOPs, Specifications, Standard Test procedures, QRM, Validation protocols & summary reports.
8. Handling of Change Control, Deviation, CAPA, OOS/OOT.
9. Perform/participate in contamination-control risk assessments & implementation of CCS.
10. Support microbiological method verification/validation. Establish microbiological testing procedures based on applicable pharmacopoeia and regulatory requirements.

Microbial enumeration

Microbiological Assay

Sterility testing

Bacterial endotoxin testing

Bioburden testing

Water microbiology

Environmental monitoring

1. Establish microbiological requirements for cleaning and disinfection programs & develop and execute disinfectant efficacy studies. Support cleaning validation with microbiological risk assessment
2. Provide Microbiological SME support for aseptic process design.
3. Develop Microbiology requirements for Aseptic Process Simulation (APS)/Media Fill .
4. Participate in media fill protocol preparation, execution and assessment
5. Ensure documentation completeness, accuracy, and compliance with data integrity principles.
6. Coordinate with cross-functional teams (Production, QA, Engineering) to align with project timelines.
7. Monitoring of training of laboratory team as per job role
8. Strong knowledge of USP, EP, JP, PICS, PDA, WHO Microbiological requirements.

EU GMP Annex 1

21 CFR Part 210 & 211

Data Integrity requirements

ISO 14644

PDA Technical Reports

Sterility Assurance Principles

Environmental Monitoring Programs

Contamination Control Strategy (CCS)

Travel Estimate

NA

Job Requirements

Education Qualification

M. Sc. in Microbiology.

Experience

Tenure : 15+ 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).