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. 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: 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).