- Responsible for day to day activities designed to maintain and enhance the local Quality Management System for 3rd Party and Commercial oversight in line with directive 91/356/EEC, as amended by Directive 2003/94/EC, veterinary directive, Medical Device Directives, ISO13485 as applicable.
- The Quality Specialist will review and co-ordination of batch records and associated documentation including the generation of product release certificates to support batch release and certification of product.
- Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures
- Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, SOP’s.
- Interface between Regulatory Affairs, Marketing and Customer Service personnel where necessary.
- The Quality Specialist will be responsible for the writing, training and management of SOPs including associated training requirements
- Maintenance of system to ensure appropriate review and completion of Annual Product Quality Reviews
- Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required
- The Quality Specialist provide direct support during competent authority audits
- Assist in conducting internal self-inspections and external audits as appropriate
- The Quality Specialist will provide quality review and approval of artwork components where applicable
- Bachelor’s Degree required with a minimum of 3 years’ experience in QA/Compliance in pharmaceuticals or related industry.
- Prior pharmaceutical or quality assurance experience essential
- Strong analytical skills and knowledge of quality system essential
- Thorough knowledge of either EU GMPs and/or Medical Device Directives
- Computer literate essential including working knowledge of MRP system
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