As a Quality Systems Manager you will oversee 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. Below are the mains duties:
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- The Quality Systems Manager 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.
- Supervisory duties for your service within the Quality Systems group.
- Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, change control, deviations, CAPAS, documentation, supplier quality management and GMP training.
- Provide oversight and management of the supplier approval programme and the external audit schedule.
- Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- To ensure that the systems with a GMP impact are maintained as per written procedures.
The next Quality System Manager must have bachelor's degree in chemistry, biology or a related scientific discipline. A minimum of 10 years working within quality in the pharmaceutical industry and a minimum of 5 years’ experience in a people management role is desirable.
A thorough understanding of quality systems and cGMP's is necessary.
Are you a self-motivated, flexible and a good team player with the ability to prioritise own work based on departmental and site requirements? Are you looking for a career progression in an innovative business? Send us your CV, this job is waiting for you!
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