QC Team Lead
An expanding Biologics site in Cork has an exciting opportunity for an experienced QC Team Leader to join their team and support this expansion. This is a permanent role with an attractive salary and benefits package on offer for the right candidate. About the Job: Performance management of a group of 10-15 QC Analysts, setting goals and objectives to challenge and develop the team members. Motivating and developing reports, providing technical expertise and leadership to help meet goals set in the performance management process. Supports the startup of the new lab areas, including equipment qualification, analytical method transfer, utility qualification and proves validation of the new manufacturing suite. Management of utility, raw material, in process and drug substance microbiology and QC testing activities. Provide technical support to manufacturing for QC issues in the plant; ensure QC support is available to support batch production process. Releases batches from QC according to site release timelines. Writing, reviewing and approving relevant QC procedures, deviations and change controls, and ensuring on time closure of records. Lead QC audit readiness team preparing for and participating in internal and external audits. Ensuring QC activities are completed in compliance with all relevant cGMP, regulatory, company quality and safety standards. Leading lean initiatives within QC, e.g. Visual Factory, GEMBA, KAIZEN and 5S. Anticipating and planning for future requirements, initiating and driving cost and process improvement projects in the area. Development and reporting on key performance indicators for the QC group. Presents technical/analytical data clearly and concisely to customers, i.e. internal investigations and regulatory inspectors etc. About You: BSc Hons (or Higher) in a Science or related discipline. A minimum of 3 years’ experience in a similar role. Excellent social and communication skills. Proven record of developing direct reports. Self-driven and keeps up to date with regulatory, technical developments within the industry. Focus on patients and customers at all times. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
70 days ago