Head Microbiology

Position : Microbiology Head

Reports to: Quality Head

Department: Quality

Grade: G8

Functional Area: QC - Microbiology

Location: Dewas

Position Summary

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 Requirements

Minimum 15years With Microbiology Work Experience Preferred

REQUIRED SUCCESS ATTRIBUTE

Knowledge 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
  

Roles