Manager Microbiology

Job Title
Manager Microbiology
Business Unit
Global Quality and Compliance
Job Grade
G10
Location :
Pithampur
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.
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.”
Coordinate equipment procurement, technical evaluation, installation and qualification.
Participate in design review, risk assessment, constructability review and GMP review from a Microbiological perspective.
Participate in DQ, FAT, SAT, IQ, OQ and PQ activities for systems impacting microbiological quality.
Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
Prepare SOPs, Specifications, Standard Test procedures, QRM, Validation protocols & summary reports.
Handling of Change Control, Deviation, CAPA, OOS/OOT.
Perform/participate in contamination-control risk assessments & implementation of CCS.
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
Establish microbiological requirements for cleaning and disinfection programs & develop and execute disinfectant efficacy studies. Support cleaning validation with microbiological risk assessment
Provide Microbiological SME support for aseptic process design.
Develop Microbiology requirements for Aseptic Process Simulation (APS)/Media Fill .
Participate in media fill protocol preparation, execution and assessment
Ensure documentation completeness, accuracy, and compliance with data integrity principles.
Coordinate with cross-functional teams (Production, QA, Engineering) to align with project timelines.
Monitoring of training of laboratory team as per job role
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 : 12+ 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).

Work arrangement
No