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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Quality Manager


Reference:SCAOXR206562 Location: Kerry
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Control Manager, Quality Control Supervisor, Quality Manager, Quality Specialist

Quality Manager
Our client, an animal health company based in Kerry, are currently recruiting for a Quality Manager to join their team on a permanent basis. As Quality Manager you will plan and supervise the activities of the Quality Control and Quality Assurance functions and the personnel working in these functions.

Responsibilities

  • Overall responsibility for QMS
  • Review and approval of all GMP documents and ensure that documents are appropriately stored and retained
  • Deviation review, approval and management
  • Change control review, approval and management
  • Co-ordinate and approve with QP, all equipment, utility, process, cleaning and analytical method validation protocols and programmes. Make decisions based on the execution of the validation programmes and analytical data derived
  • Liaise with the QP and ensure that Quality Risk Management principles are taken into consideration in designing quality systems and in making decisions relating to operating conditions and batch release
  • Develop an internal audit schedule based on risk management principles and ensure that audits are conducted and appropriate actions are taken
  • Approve and monitor material suppliers, contract laboratories and other out-sourced activities by technical agreement, auditing or testing of samples as required
  • Non-conformance review and follow up of corrective and preventive actions
  • Ensure ongoing training on changing requirements of GMP and on the job training is provided to all personnel
  • Ensure that the manufacturing environment is monitored and controlled in conjunction with the Production Manager including HVAC systems, plant hygiene, process controls, storage conditions etc
  • Compile and trend data related to all QA systems (complaints, deviations etc.)and products (rejects, PQR etc.) and present this data to the QP and Senior Management group to ensure that appropriate corrective and preventive actions are taken and resources are made available
  • Assist the QP, in constant striving for continuous improvement on the quality of product and processes
  • Liaison with members of HPRA and other regulatory bodies as required
Requirements
  • A degree in Science or a related discipline from a recognized University
  • Ideally 5 years’ experience in the pharmaceutical or allied industries in a similar role
  • People Management experience ideal
For more information please contact Sinéad Cullen on +353879500821 or [email protected]