The Quality Systems Specialist is responsible for the coordination of key Quality Systems related activities within the Quality Systems group and for varying duties as assigned by the Quality Systems and Compliance Manager.
What does this job involve?
- Provide oversight and management of key elements of the Quality Management System (QMS), which include, Supplier Quality Management and GMP training. Supporting other elements of the quality systems group, including but not limited to, change control, deviations, CAPAS, documentation.
- The Quality Systems Specialist will provide oversight and management of the supplier approval programme and the external audit schedule.
- Develop and write SOP & Controlled Documents.
- Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Thq Quality Systems Specialist will 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.
- The Quality Systems Specialist will actively support the development/implementation and continuous improvement of the Quality Management Systems.
- Participate in other projects as directed by the Quality Systems & Compliance Manager.
The next Quality Systems Specialist should have a bachelor's degree in Science with a minimum of 8 years working within quality in the pharmaceutical industry. You should be an SME in Supplier Quality Management and GMP training demonstrating excellent communication skills and attention to detail.
If you're looking to join one of the worlds largest pharma companies who offer excellent flexible work options then get in touch now!
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