Laboratory Operations Manager

3 days ago


Limerick, Limerick, Ireland Cook Medical Full time

Job Description

  • The Team Lead, Analytical Laboratory will be responsible for coordinating and supervising all activities involved in the running of an efficient and effective analytical laboratory.
  • This includes scheduling of testing and release of product from the laboratory upon completion of testing.

Responsibilities

  • Provide technical and problem-solving support to the team as required. (Knowledge of UV Vis, Dissolution and HPLC Equipment and techniques are a prerequisite).
  • In-depth knowledge of Agilent HPLC's, Empower and Chemstation Software required.
  • Carry out project work as required, particularly associated with the implementation of new specifications and methods of analysis required to comply with pharmacopeia or customer requirements.
  • Co-ordinate Stability Programme.
  • Manage the maintenance and calibration of analytical equipment and review and approval of associated documentation. Ensure laboratory CFR21 Part 11 adherence and qualification of new equipment.
  • Evaluate the finished product and raw material analysis prior to shipment/use and completion and approval of associated documentation.
  • Maintain acceptable work standards (e.g. safety, environmental, cGMP housekeeping etc.) agreeing targets and objectives and evaluating achievement of these objectives.
  • Review and approve Laboratory Investigations and CAPA's in a timely manner.
  • Ensure laboratory audit readiness at all times and participate in audits (internal and external) and inspecting as required.
  • Identify training gaps present in the team and take necessary measures to close these gaps and ensure this training is documented as per company procedures.
  • Review performance achievements, formally and informally, with the team members with a focus on improvement.
  • Ensure all laboratory documentation is kept up to date.
  • Delegate for the Manager, Analytical Laboratory once trained on relevant procedures/tasks.
  • Provide monthly reports and Quality Metrics in a timely manner.


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