The QA Senior Specialist is responsible for implementing and monitoring the operation of the Quality Management systems in place under the company’s Wholesale Distribution Authorization according to current legislative requirements including EU Good Distribution Practice
Essential Job Duties and Responsibilities:
Ensure that a quality management system proportionate to the distributor’s activities is implemented and maintained including: self inspection; quality risk management; corrective and preventative actions (CAPA) to address deviations; recall; change control; vendor management
Paricipate/lead in internal and external compliance audits
Support regulatory inspections
Collaborate cross-functionally with local and global colleagues to ensure all quality standards are adhered to and to identify and implement process improvements in distribution of materials and finished products
Participate in inter-site global projects
Liaise and co-operate with all regulatory bodies on behalf of the company
Manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP
Ensure relevant customer complaints are dealt with effectively
Coordinate with MAH and CMOs and promptly perform any recall activities required for medicinal products
Co-operate with marketing authorization holders and national competent authorities in the event of recalls
Minimum of a Bachelor’s Degree in Science or a healthcare related field and a minimum of 4-6 year's relevant experience of medicinal products is required.
Excellent knowledge of Good Manufacturing Practice(GMP), Good Distribution Practice (GDP) Wholesale Distribution Authorisation (WDA).
Experience of working in a virtual supply chain environment a distinct advantage
Working knowledge of logistics and serialization would be desirable.
€300 daily rate contractor based in Dublin City Centre - contact Clara on 01 4744676 or email email@example.com
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.