Head Microbiology

Title

Head Microbiology

Business Unit

Quality

Job Grade

Senior Manager

Location:

Dewas

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

Key responsibilities:

• Ensure compliance to cGMP and safety standards in the Microbiology Lab.
• Conduct work planning and allotment to analysts for sample testing.
• Ensure Calibration/Preventive Maintenance/Qualification of laboratory equipment and instruments
• Ensure environmental monitoring of Microbiology Laboratory.
• Ensure sample management & sanitization activity in Microbiology lab sample
• Ensure microbiological analysis of sterile and non-sterile raw materials, in-process samples and finished products, PM and Stability.
• Evaluate and ensure analytical data and calculation of results.
• Assist with reporting and verification of test results/reports.
• Ensure timely preparation of Validation protocols/reports other quality documents.
• Initiate /execute QMS activity pertaining to micro lab activity.
• Ensure review & approve QMS activity pertaining to micro lab activity.
• Provide microbiological support in plant validation & qualification activities.
• Provide troubleshooting support to analysts.
• Ensure for in process activities related to Sterility Assurance on shop floor.
• Ensure timely training and qualification of all Microbiology personnel as per schedule/requirement.
• Coordinate for various activities with laboratories & manufacturing/customer's and ensures to provide timely & necessary support to fulfil organizational requirements.
• Support IPQA, QA, Production, PDL, Regulatory, Stability Lab, API and Validation for microbiological requirements.
• Co-ordination for internal/external audits, and ensure compliance during internal as well as regulatory audits.
• Ensure conformance to internal Quality Systems requirements and relevant markets' regulatory guidelines on cGMP with respect to Microbiological requirement.
• Ensure for technical up gradation of activities whenever required.
• Actively participate in all Validation, Qualification and process enhancement activities and to ensure conformance to internal Quality Systems requirements and relevant markets' regulatory guidelines on cGMP with respect to Microbiological requirement.
• Ensure training on revised SOPs/GPs/Protocols and other quality documents to analysts in Microbiology Laboratory.
• Ensure Identification & assessment of Microorganisms.
• Ensure Disinfectant Efficacy Test (DET).
• Ensure Container Closure Integrity Test (CCIT).
• Ensure for Biological indicator inoculation, incubation and observation.
• Ensure for Media Management and GLP activities with respect to Microbiological requirement.
• Ensure and Review of Change controls, SOP's, STP's, GP's & Validation protocols/reports and other quality documents for accuracy and completeness with respect to Microbiological requirements.
• Ensure timely revision & implementation of various effective documents i.e. GSOPs/SOPs/GPs/Protocols etc.
• Ensure timely preparation of Monthly trends, Quarterly summary and annual summary reports of water samples.
• Ensure timely Conduct microbiological & chemical testing of the water systems.
• Ensure timely performed BET of water samples, preparation of chemical reagents and sampling activities of water system.
• Ensure Analytical Method validation with respect to Microbiological requirement.
• Review and approval of SOP's in EDMS.
• Accountable for overall compliance in Microbiology Laboratory.
• To ensure contamination controls implemented and followed at site as per Contamination Control Strategy (CCS) and respective procedures.
  
  

Travel Estimate

Job Requirements

Educational Qualification

M.Sc. In Microbiology

Experience

15 – 20 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).
Skills Required
analytical method validation , sterility assurance , sample management , Environmental Monitoring, Microbiological Analysis