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QA Lead QP

Ref: 77890

  • Negotiable
  • 21 Sep 2022
  • Wicklow
  • Permanent

QA Lead QP

About the Company

My client is a leading Global Healthcare group with multiple sites across Ireland. They develop, manufacture, and supply a range of Pharmaceuticals, Biologics, Medical Devices and Diagnostics in more than 100 countries. They have a presence in Ireland with multiple manufacturing operations and corporate offices. Due to success and a scale up of operations, they are hiring a Senior QA to lead batch release activities at their site in Wicklow and act as QP on their manufacturing license. 

About the Position

Reporting to the Site Quality Director you will be Compliance and Product Release Manager and named on license for the site. You will work closely with the other Quality leads who look after Operations, Systems and QC. This is a permanent site based role but will offer flexibility to work from home in a hybrid working model. 

Key Responsibilities

  • To oversee the Site License registration process
  • Approve Laboratory, Manufacturing and Packaging Master Batch Records
  • Primary responsibility for Manufacturing and Product release activities onsite - fulfill the role of QP Batch Releaser
  • Ensure that Product release is in compliance with the registration files
  • Regulatory Compliance Surveillance and application for the Site QMS
  • Owner for Auditing and Regulatory Inspection Management, working in close collaboration with the other Quality Leads to ensure continuous site inspection readiness
  • Direct line management of a small team (1 x Senior QA Specialist who supports batch release activities with potentially more as the function grows)
  • Quality oversight across the entire Quality function onsite 

Experience/Requirements

The role requires a confident Quality professional who is QP qualified / eligible with good leadership capabilities. 
  • A Degree in Science, Engineering or related 
  • 7-10 years industry experience (Pharmaceutical or Biotechnology) 
  • QP qualified or eligible
  • Strong Site based experience in quality control, quality assurance or manufacturing operations
  • Strong leadership, communication, decision making, and problem-solving skills
  • Adaptable and flexible towards work 
  • Eligible to live and work in Ireland and work onsite in a hybrid model

Remuneration Package

Excellent global benefits package on offer with an extremely competitive base salary. Salary will depend on experience and skills. 
Contact

For more information on this role or any other Life Sciences roles contact Gillian McMurrough on +353871213548 | email | click on the apply button below.

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