Quality Systems Specialist

Job description

As a Quality Systems Specialist you will oversee the coordination of key Quality Systems related activities within the Quality Systems group.  Your mains duties will include:

  • 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 the 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 SOP & 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 and management 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.
  • Provide oversight and management of the supplier approval programme and the external audit schedule.
  • Work directly with other key departments to ensure compliance and productive working relationships.

The next Quality Systems Specialist must have bachelor’s degree in chemistry, biology or a related scientific discipline. With a minimum of 10 years working within quality in the pharmaceutical industry. A SME in Supplier Quality Management and GMP training is desirable.

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

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