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Microbiology Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Scientific
  • Date posted: 12/09/2017
  • Job reference: J373911A

Job Title:

Microbiology Manager

Job Purpose:

Manage and co-ordinate all activities in the Microbiology Laboratory including scheduling and people management

Responsibilities:

  1. Site expert on microbiology; providing company-wide guidance and expertise
  2. Introduce microbiological testing and provide support to the site including scheduling of all activities within Microbiology laboratory
  3. Co-ordinating and managing Microbiology Analysts and supporting them in their role
  4. Managing the Microbiology laboratory schedule to support operational activities
  5. Perform support equipment URS, equipment implementation and laboratory set up
  6. Ensuring that the existing laboratory tools are used to generate and maintain performance related metrics
  7. Execution of routine utilities QC-Micro testing and environmental monitoring compliance with cGMP and Standard Operating Procedures
  8. Oversee the timely close out of deviations and/or investigations
  9. Ensure the timely completion of data reviewing as required
  10. To identity training requirements of Microbiology Analysts within laboratory and organize training as required
  11. To draft procedures and company documentation as required
  12. 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.
  13. Ensure microbiology laboratory personnel adhere to all good housekeeping practices
  14. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  15. Representing the Microbiology laboratory at various meetings
  16. Health & Safety
    • Ensure requirements of Safety Statement are implemented
    • Continuously promote a positive safety culture by leading by example
    • Implement safety requirements as per site documentation including SOP's, Safety Statement and COP's
    • Report any defects
    • If unsure about safety requirements - ask

  1. Ensuring the Microbiology laboratory adheres to highest standards of GLP including right first time
  2. Managing all external laboratory testing, ensuring all testing is completed on time in full
  3. Recruit, train, manage and develop team
  4. To perform additional tasks as agreed to support effective running of the business.

Minimum Qualifications & Experience

  1. Qualified to a minimum of degree level in science discipline with a post-graduate qualification advantageous
  2. At least 5 years' experience in microbiology pharmaceutical laboratory; startup project experience an advantage
  3. Previous experience in injection facility/sterile fills desirable
  4. Good working knowledge of Regulatory Guidance for manufacture of sterile fill finish products
  5. Supervisory management experience advantageous
  6. Previous cross-functional project experience
  7. GLP expert
  8. Knowledge of GMP guides

Other Information

Skills and Behavioural Competencies

Skills

  1. Microbiology expert
  2. People management skills
  3. Multi-tasking, ability to manage conflicting deadlines
  4. Analytical techniques
  5. Operation of laboratory instrumentation
  6. Computer Skills to include MS office, ECDL certification an advantage
  7. Proven time management skills
  8. Planning & organising
  9. Project management, knowledge of MS project

Behaviours

  1. Leadership
  2. Influencing
  3. Decisiveness
  4. Ability to deal with cross-functional groups
  5. Teamwork & Collaboration
  6. Compliance & adherence to regulations
  7. Safety Awareness
  8. Ability to handle pressurized timelines
  9. Attention to detail
  10. Problem Solving / Analysis
  11. Adaptability
  12. Lean-thinking

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