Team Lead, Analytical Laboratory

4 weeks ago

Limerick, Limerick, Ireland Cook Medical Incorporated Full time

Overview
The Team Lead, Analytical Laboratory will be required to coordinate and supervise all activities involved in the running of an efficient and effective analytical laboratory.
Responsibilities
To coordinate and supervise all activities involved in the running of an efficient and effective Analytical laboratory including scheduling of testing and release of product from the laboratory upon completion of testing.
To 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.
Also 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 evaluation of achievement of these objectives.
Review and Approval of Laboratory Investigations and CAPA's in a timely manner.
Ensuring laboratory audit readiness at all times and participate in audits (internal and external) and inspecting as required.
To 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.
Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
Qualifications
BSc / Masters desirable and/or relevant experience.
Excellent technical knowledge of the team's area of responsibility.
Previous supervisory experience desirable
Ideally a minimum of 5 years experience within a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry.
Excellent organisational skills are required for this role.
A minimum of 5 years analytical laboratory experience.
Proven People management, problem solving and leadership skills.
Computer literacy.
Willingness and availability to travel on company business.
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