ANALYTICAL DEVELOPMENT & PROJECT MANAGER required by CareerWise Recruitment for our for our multinational generic pharmaceutical client in Cork, approx. 50% of time will be spent in the lab.
The ANALYTICAL DEVELOPMENT & PROJECT MANAGER will be primarily 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.
Role of this position
- Ensure compliance with cGMP's, Environmental, Health & Safety regulations within the laboratory.
- Manage & promotes the maintenance of a safe, accident free and healthy work environment within the laboratory & aligns with the QC Manager to assure 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 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, prepares and executes procurement of equipment & software, qualification; calibration and maintenance for the laboratory.
- Support the Change Control process.
- Provide input to the Quality Management Review process & support the review meetings.
- Support & provide input to the annual laboratory budget.
- 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.
- BSc in a scientific discipline.
- Minimum of five (5) years in a cGMP facility in a Laboratory role.
- Previous experience in managing or supervising direct reports is essential and experience using project management tools is desirable.
- Experience in HPLC and UPLC (High Performance Liquid Chromatography), method development & validation including equipment & software qualification is required.
- Knowledge of lean laboratory operations would be an advantage.
Please call Conor Twomey today for further information on 087-0907204 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)