Job Description

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.

Sun Pharmaceutical Industries