Description:

We are seeking applications from experienced Microbiologists with at least 5 years’ experience in a microbiology pharmaceutical laboratory, previous experience in injection facility/sterile fills desirable as well as good working knowledge of Regulatory Guidance for manufacture of sterile fill finish products with supervisory management experience advantageous.

Responsibilities include:

• Site expert on microbiology; providing company-wide guidance and expertise (join project team responsible for setting up Micro lab and facility)
• Introduce microbiological testing and provide support to the site including scheduling of all activities within Microbiology laboratory
• Co-ordinating and managing Microbiology Analysts and supporting them in their role
• Managing the Microbiology laboratory schedule to support operational activities
• Perform support equipment URS, equipment implementation and laboratory set up
• Ensuring that the existing laboratory tools are used to generate and maintain performance related metrics
• Execution of routine utilities QC-Micro testing and environmental monitoring compliance with cGMP and Standard Operating Procedures
• Oversee the timely close out of deviations and/or investigations
• Ensure the timely completion of data reviewing as required
• To identity training requirements of Microbiology Analysts within laboratory and organize training as required
• To draft procedures and company documentation as required
• To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines
• Ensure microbiology laboratory personnel adhere to all good housekeeping practices
• To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement
• Representing the Microbiology laboratory at various meetings
• Ensuring the Microbiology laboratory adheres to highest standards of GLP including right first time