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▷ (21/09/2025) Head Microbiology

4 weeks ago

Dewas Madhya Pradesh, India Sun Pharmaceutical Industries Full time

JOB DESCRIPTIONPosition Microbiology HeadReports to Quality HeadDepartment QualityGrade G8Functional Area QC - MicrobiologyLocation DewasPOSITION SUMMARYManage overall site microbiology department wrt sampling testing planning qualifications media fill program for sterile manufacturing compliance and upgrades of facilities and procedures Conduct effective review of team and portfolio provide direction and guidance to the team and develop team competence with the objective of ensuring the quality of products released with adherence to GMP norms and timelinesThe incumbent will assure individual compliance with the all concerned regulatory requirements GxP s and applicable department programs including training documentation Standard and Procedures Key responsibilities Provide leadership and direction to achieve all quality goals Manage Organize timely microbiological sampling testing and release of raw materials finished product commercial stability Exhibit stability miscellaneous samples Manage Organize timely Microbiological sampling testing and release of water and Utility samples Manage Organize timely Microbial Environmental Monitoring of passive air active air Compressed air equipment surfaces personnel monitoring Drain points of manufacturing blocks warehouses Microbiology lab etc Monitoring effectiveness of the disinfectants used at the site and make appropriate timely change to the ineffective proved disinfectants Manage Organize timely handling maintenance of microbial cultures Isolation identification of microbial isolates from various sources Manage Organize timely laboratory investigation of out of specification results Out of trends Out of limit root cause analysis and Risk assessment and Health hazard evaluation of identified microorganisms Participate in internal external and or regulatory inspections of Microbiology operations at the site Learn from external regulatory audit observations and implement Global CAPA and local CQA observations CAPA in micro lab Ensure trend and annual summary reports of water microbial environmental monitoring Microbial isolates etc Ensure calibration validation and qualification of laboratory equipment instrument Ensure timely availability of laboratory Chemicals media stationary gloves and Consumable Ensure consistency in Microbiology lab operations and drive continuous improvements in laboratory performance Ensure compliance to cGMPs and applicable safety standards in the Microbiology laboratory Train microbiologist about the microbiological techniques aseptic practices critical quality management skills including decision-making handling of quality exceptions staff development personnel and planning etc Managing people on a day-do-day basis Preparation of annual capex revenue budget for microbiology section Ensure adherence to approved budget work plan Oversee that the cost of testing is controlled in microbiology lab Liaison with Corporate Micro team to implement microbial risk assessment program and work to mitigate effective CAPA s to prevent failures MINIMUM EDUCATION EXPERIENCE REQUIREMENTSMicrobiology Graduateor Equivalent Minimum 15years with Microbiology work experience preferredREQUIRED SUCCESS ATTRIBUTEKnowledge of GxP s cGMP and other regulatory requirements Compliance Collaboration Accountability Customer service orientation Planning and prioritization Secondary Success Attributes Attention to detail People connect Emotional control Effective communication Problem solving RolesAdditional responsibilities can be assigned as required