Job Description

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).

Skills Required