- BBBH790922 Aug 20, 2021 Competitive
Excellent opportunity for an experienced Analytical Development Manager to join a pharmaceutical company in Cork. See below to apply today!
We are now hiring an Analytical Development Manager on behalf of our client in the pharmaceutical industry based in Cork on a permanent basis.
This role will be responsible for technical activities within the Laboratory, this includes management of method development & verification of test methods, creating/approving test method's & specifications, training specialists to test methods & specifications for New Product Introduction, environmental, health & safety of direct reports.
In addition, you will manage projects such as procurement, installation & qualification of new equipment & software, annual equipment maintenance & calibration, support the New Product Introduction process & the Quality Management System.
- Ensure compliance with cGMP's, Environmental, Health & Safety regulations within the laboratory
- Manage & promote the maintenance of a safe, accident free and healthy work environment within the laboratory & align with the QC Manager to assure the same.
- 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 Laboratories 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
- Manage & develop the key performance indicators (KPIs) for the areas within your responsibility to monitor performance and identify areas for improvement
- 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, prepare and execute procurement of equipment & software, qualification; calibration and maintenance for the laboratory
- Provide input to the Quality Management Review process & support the review meetings
- Support & provide input to the NPI process
- Develop and implement Standard Operating Procedures for your area of responsibility
- Maintain familiarity with current regulatory trends
- Function as delegate for the Quality Control Manager in their absence
- Manage assigned projects as necessary
- Perform related duties as assigned
- BSc in a scientific discipline; minimum of 5 years in a cGMP facility in a Laboratory role.
- Experience in HPLC and UPLC, method development & validation including equipment & software qualification is required.
- Knowledge of lean laboratory operations would be an advantage.
- Previous experience in managing or supervising direct reports is essential
- Ability to effectively manage and participate in cross-functional problem-solving teams, using root cause analysis & project management tools
- Excellent knowledge of Quality Assurance, cGMP, GLP, method development, validation & equipment qualification.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Consultant | Engineering Recruitment
353 (0) 21 2300300