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Quality Systems Specialist

Job description

Quality Systems Specialist role on long term contract with a company known for their global facilities and their multiple high-quality product range produced with an innovative process.

As a Quality Systems Specialist you will oversee the coordination of key Quality Systems and related activities within the Quality Systems group.  Your main duties will be the following :

  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.
  • Assist and co-ordinate implementation of global standards and procedures into site Quality Systems.
  • Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Develop and write SOPs & Controlled Documents.
  • Provide oversight and management of key elements of the Quality Management System (QMS), which include Supplier Quality Management and GMP training.
  • Provide oversight of the supplier approval programme and the external audit schedule.
  • Support other elements of the quality systems group, including but not limited to, change control, deviations, CAPAs, documentation.
  • Work directly with other key departments to ensure compliance and productive working relationships.

The Quality Systems Specialist must have bachelor’s degree in chemistry, biology or a related scientific discipline. Also essential a minimum of 4 years' working within quality in the pharmaceutical industry.

Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas is required.

For this position it is important to be self-motivated, flexible, organised and a good communicator. Also willingness to work on a shift schedule is necessary.

If you recognise yourself in the above description and want to work with an established and innovative company, send us your CV in confidence for review.

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