Laboratory Manager (m/f)

  • Overall responsibility for management of the Analytical Services Laboratories (Analytical, Microbiology & Phage laboratories) to cGLP standards
  • Overall responsibility for co-ordination of routine lot release testing to meet shipment deadlines and service level agreements
  • Overall Responsibility for Method Development and troubleshooting in the Laboratories
  • Overall responsibility for validation and Lifecycle Management of Computerized systems and Equipment in the Laboratories
  • Overall responsibility for the Data Integrity Improvement program within the Laboratories
  • Coaching and Mentoring of colleagues to develop and nurture a high performing laboratory team
  • Implementation of the Quality improvement initiatives in the Laboratories
  • Ensuring compliance of the Laboratories to all applicable quality, regulatory and pharmacopoeia requirements
  • Maintaining and improving the systems for laboratory investigations, CAPA (Corrective and Preventative action) and change control
  • Providing support to the manufacturing areas on troubleshooting and development
  • Responsibility for environmental testing program and GMP initiatives
  • Responsibility for Development and Control of the laboratory Budget
  • Participate in the Internal Audit Program and support Customer and Regulatory audits as required
  • Responsible for ensuring compliance with all applicable Environmental, Health and Safety legislation & adherence to procedures for area of responsibility
  • B.Sc in Science (Chemistry, Microbiology etc)
  • Extensive industry experience with laboratory supervision experience desirable.
  • Excellent analytical, troubleshooting and technical writing ability
  • Knowledge of Lean Labs and Operational Excellence methodologies desirable
  • Detailed regulatory knowledge and experience of cGLP

» Job description

Merck KGaA
Munster-Carrigtwohill [IRL]

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