Quality Assurance Manager - UK
Our client strives to offer a meaningful difference in people's lives; it's a fast-growing company that rewards initiative and achievement with an excellent range of employee benefits!
The UK Quality Assurance Manager's responsibilities include:
* Managing UK LRD Quality Assurance Systems and team in line with global, regional and local quality and regulatory requirements.
* Performs the role of Responsible Person registered with the MHRA for our client Wholesale Dealer's Licence (WDA (H)).
* In collaboration with Corporate QA and in-country QA, manages all activities associated with the investigation of significant non-conformance relating to medical devices, within the region
* Ensures adequacy and completeness of risk evaluation, product containment, distribution reconciliation, product recall and recall effectiveness, as necessary
* Develops QMS to comply with standards, regulations, corporate, regional and local quality requirements
* Ensures compliance with Corporate QA, GDP, GMP and national requirements, and consistent implementation of QMS across the region, and promotes continuous improvement culture on site
* Manages QA self-inspection programmes for GDP, technical agreements with distributors and manufacturers, quality and vigilance including auditing on behalf of Global Quality, as required
* Manage training and development, internal audit program including audit schedules, audit commitment tracking, local complaint handling for all pharmaceuticals and medical devices, local and regional deviation/CAPA systems, document control and related training systems, and significant non-conformance and recalls
The ideal candidate will have/be:
* Experience with GDP inspections and third party audits
* Understanding of pharmaceutical manufacturing and third party logistics (including familiarity with various analytical techniques) a strong asset
* Experience of quality requirements through the whole value chain: Manufacturing, Third Party Distribution and Post Marketing activities
* Knowledge of Quality Management requirements for MAA holders and distribution
* Experience in Quality System Management and writing SOPs, as necessary
* Experience interacting with Competent Authorities and Notified Bodies, ideally hosting of audits
* Experience in managing a small quality team
* Experience in European Union GDP requirements for medicinal products
* Experience of conducting audits to ensure compliance of QMS
Apply for this Quality Assurance Manager opportunity now via this website or contact Will on 01628 581 240!
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.