Head Microbiology

Title Head - Microbiology Business Unit SGO Quality Job Grade Senior Manager Location Mohali Key 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 JOB DESCRIPTION Responsible for Oversight and Monitoring of Microbiology Laboratory at the site This position shall be responsible to assure Microbiological quality of Sun Pharma products manufactured at site and distributed to global markets including USFDA Provide leadership and direction to ensure achievement of all Quality Microbiological goals Organize Microbiological testing and release of different type of samples i e raw materials finished product commercial stability Exhibit stability miscellaneous samples Organize Microbiological testing and release of Raw Potable Purified water samples Organize Microbial Environmental Monitoring of passive air active air compressed air equipment surfaces personnel monitoring drain points of manufacturing associated environment of Manufacturing blocks ware houses Microbiology lab Organize handling Maintenance of microbial cultures Isolation and identification of microbial isolates from various sources Ensure effective system for maintaining microbial cultures Participate in the investigation of out-of-Specification results out of trends results conduct investigation for root cause analysis corrective actions and systems to ensure compliance to quality requirement Handling of Change control and CAPA management Participate in external and or regulatory inspections of Microbiology operations at the site Ensure preparation of trend and annual summary reports of Raw Potable Purified water Microbial environmental monitoring Microbial isolates etc Ensure consistency in Microbiology lab operations and drive continuous improvements in laboratory performance Ensure compliance to cGMP GLP and applicable safety standards in the Microbiology laboratory Accountable for all product compliance related activities being performed in the Quality Control Microbiology Laboratory Responsible for imparting training to employees as a qualified trainer Determine and make available resources staff instruments training lab space etc in microbiology function at the site Responsible to perform the internal audit as per the site specific procedures Performs all work in support of our Corporate Values of Pride Accountability Integrity and Diligence Performs all work in accordance with all established regulatory and compliance and safety requirements Review log books Instrument calibration records Instrument Periodic performance records data summary reports and certificate of analysis for accuracy and completeness Any other activities assigned by Site Quality Head Travel Estimate Low Job Requirements Educational Qualification M Sc Microbiology Experience 15 to 20 Years with USFDA plant experience is mandatory 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