Quality Compliance Associate

Job description

The Quality Compliance Associate is responsible for the coordination of compliance activities within the compliance group and for varying duties as assigned by the Quality Compliance Executive.  Some key tasks and responsibilities are outlined below.

  • Assisting in oversight and management of key elements of the Quality Management System (QMS) within the compliance group, which includes but not limited to, inspection management, metrics/KPIs, Quality council, product quality communications, Product Complaints, Risk Management and Regulatory Compliance.
  • The Quality Compliance associate will participate in the internal audit schedule.
  • Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Preparation of Key Performance Indicators to align with company and global quality objectives.
  • 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.
  • Participation in the preparation of documentation for regulatory submissions.
  • To ensure that the systems with a GMP impact are maintained as per written procedures.
  • Assist in implementation of global standards and procedures into the site Quality Systems.
  • To actively support the development/implementation and continuous improvement of the Quality Management Systems.

The next Quality Compliance Associate should have a bachelor's degree in chemistry, biology or a related scientific discipline with a minimum of 3 years working within quality in the pharmaceutical industry.

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