Job Details for Quality System Specialist

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What you need to know

You will work as a Quality System Specialist in South Dublin for our client in the pharmaceutical industry.

You will develop and deliver employee training on Quality management system and related quality manual documents. You will provide leadership in the design and development of QMS programs.

This a 1 year contract role and the salary is negotiable.

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Key duties & responsibilities:

  • Planning, leading and coordinating activities involved in the design/development, implementation and governance of a harmonized Quality Management System (QMS) program including Quality policies, standards, and procedures.
  • Ensuring cGMP compliant and cost efficient QMS system fully integrated into global and site business processes and continuously improved through Quality subject matter expertise.
  • Providing leadership, QMS expertise and facilitation of strategies for complex or cross-site/ cross-product quality system remediation efforts.
  • Collaborating with stakeholders and customers at internal and external sites to ensure alignment of Quality systems throughout the internal network and across the standards and procedures.
  • Implementation of business processes for integration of QMS management into relevant elements of the internal site and external network operations.
  • Deploying the QMS Training Program and developing and training personnel, including internal stakeholders and customers on redesigned Quality Management Systems.
  • Ensuring alignment of approaches, policies, standards and procedures used to the greatest extent possible across the Quality groups responsible for Biologics and Vaccines product platforms.
  • Maintenance of a robust change control system for the redesigned QMS to ensure compliance with latest regulatory requirements and to maintain alignment of MMD quality documents with local site guidance internally and externally.

 

What are we looking for?

  • Bachelor degree in Biology, Biochemistry, Chemistry, Biomedical Engineering, Chemical Engineering or related scientific disciplines.
  • 7 years’ experience in the pharmaceutical, biopharmaceutical, medical devices or related industry.
  • Expert knowledge of cGMPs, Quality system expectations and associated Quality Manual Documentation at the policy, standard and procedure level.

 

 

Apply for this job now or get in touch with Joanne on 01 4690901.

Matrix Recruitment Group is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent.

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Recruitment Consultant: Joanne Foley

Job Title: Quality System Specialist

Reference: 888015

Maximum file size: 64 MB.

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Job Title: Quality System Specialist

Reference: 888015

Maximum file size: 64 MB.