My client, a leading manufacturing company based in the midlands currently have a requirement for a Quality Systems/Compliance FDA Engineer.
Responsibilities:
Co-ordinate the execution of the site FDA-readiness action plan(s) via project-management leadership and interaction with all functional areas.
Lead sub-system improvement teams e.g. material control, CAPA etc.
Support FDA-readiness training and awareness activities.
Analyse quality sub-system compliance requirements, identify gaps to site quality system and lead efforts to address gaps.
Support site change control system by providing guidance to document / system owners to ensure systems and changes remain compliant.
Liaise with area owners to identify Quality system risks and co-ordinate improvement plans.
Demonstrate an understanding of the application of the Quality Policy through daily activities.
Maintain vigilance to ensure adherence to the Quality Policy and system procedures by promptly reporting noncompliance issues to management.
Bring potential Quality systems compliance issues to the attention of Quality Management.
Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the clients Global & Technical Standards.
Requirements:
Third level qualification in a Biomedical / Scientific / Quality discipline with 2 years in Quality, Technical, Regulatory or Manufacturing areas within the pharmaceutical or devices industry
To apply for this position please forward your details to xxxxxx@xxxxxxxxxxxxxxxxx.xx
Please note: Your details will not be put forward to the company without your prior permission
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