Reporting into the Director, Quality & Regulatory, the Analytical Development and Project Manager will be responsible for technical activities within the Laboratory, including management of method development & verification of test methods, creating/approving test method’s & specifications, training specialists to test methods & specifications for New Product Introduction.
Overview of Main Responsibilities (full job description available on request):
Ensure compliance with cGMP's, Environmental, Health & Safety regulations within the laboratory.
Manage and develop direct reports.
Perform regular one to one meetings with direct reports to manage team’s performance & development.
Ensure compliance & execute all activities to the copany Quality Management System such as deviations; change control, document control system, record retention & CAPA.
Manage & execute all method development & verification of test methods from receipt of samples to ensure timely implementation of test procedures to enable testing of finished products to meet launch timelines.
Manage & execute agreed improvements to test methods & equipment related issues in response to CAPA actions, non-tests or non-conformances.
Provide technical support to Quality Control to support testing and trouble-shooting as needed.
Provide training on all new test methods and specifications to assure compliant, efficient and effective testing of products.
Manage, prepares and executes procurement of equipment & software, qualification; calibration and maintenance for the laboratory.
Support & provide input to the annual laboratory budget.
What the ideal candidate looks like:
BSc in a scientific discipline.
Minimum of five (5) years in a cGMP facility in a Laboratory role.
Experience in HPLC and UPLC, method development & validation including equipment & software qualification is required.
Previous experience in managing or supervising direct reports is essential and experience using project management tools is desirable.
What you will get in return:
Competitive Salary (depending on experience).
For a confidential discussion and more information on the role, please contact Aisling Lane.