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Scientific & Laboratory

Job Description

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.

JOB REQUIREMENTS

  • 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: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie