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Senior QA Specialist

Ref: 77943

  • Negotiable
  • 17 Sep 2022
  • Wicklow
  • Permanent

Senior QA Specialist

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 Specialist to support batch release activities at their site in Wicklow. 

About the Position

Reporting to the QA Manager (QP) and working closely with the other Quality departments across Operations, Systems and QC - you will ensure compliance and execution of batch release activities. This is a permanent site based role but will offer flexibility to work from home in a hybrid working model. 

Key Responsibilities

  • To collaborate with all departments to ensure that key quality systems are operated and maintained in a compliant manner
  • Review and check of Batch Documentation prior to final release
  • Coordinate the Annual Product Review programme
  • Support investigations as required
  • To support and maintain the QMS which will include: 
    • management and approval of documentation 
    • perform CAPA's
    • change controls
    • product record review
    • investigations
    • complaints
  • To support the site to ensure compliance and excellence to always maintain site inspection readiness for audits 

Experience/Requirements

  • A Degree in Science, Engineering or related 
  • 3-5 years industry experience (Pharmaceutical or Biotechnology) 
  • QP eligible / Newly qualified QP / desire to pursue a QP qualification - desirable 
  • Excellent QMS experience in a manufacturing setting 
  • Good site inspection  / site audit experience 
  • Adaptable and flexible towards work 
  • Strong communication, decision making, and problem-solving skills
  • Ability to work on own initiative - self starter
  • Good relationship builder - enjoys working in a team
  • 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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