Quality Compliance Associate - Blackpool
CK Group is recruiting for a Senior Quality Compliance Specialist to join a global leading pharmaceutical and medical device company in Blackpool. This role will be an initial 6 month contract which may be extendable.
The Company: Our client has one of the world's most comprehensive portfolios of orthopaedic and neuro products and services for joint reconstruction, trauma, spine, sports medicine, neuro, cranio-maxillofacial, power tools and biomaterials.
Location: Blackpool is a coastal resort on the Lancashire coast in North West England. The town is situated on the Irish Sea, 15 miles northwest of Preston, 27 miles north of Liverpool, 28 miles northwest of Bolton and 40 miles northwest of Manchester. Blackpool offer many attractions including Blackpool Tramway, Pleasurebeach and Blackpool Tower. Blackpool can be reached via the M55 from the M6 and there are local bus services which run from Preston, Lancaster, Nelson , Southport and Fleetwood.
The Role: This role provides Compliance and Quality Systems support to the Blackpool site. This includes the procedures and records required for the development of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive. You will:
- Be responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Ensure that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
- Manage & maintain internal Audit schedule by agreeing annual requirements with management.
- Coach and guide Quality Operations/System and support staff as required to ensure appropriate control systems are in place and continually optimised to meet changing regulatory, corporate and industry standards.
- Ensure all assigned quality actions, and all internal and external audit observations, are investigated, have causes identified actions plans completed, and appropriate effectiveness monitoring performed to the agreed schedule, regardless of source.
- Perform Internal Audits to schedule and complete audit reports and effectiveness reviews.
- Lead the external audit inspection readiness program for the site.
- Provide Front Room/Back Room support during external audits.
- Manage the response process for all external audit commitments. (From creation to closure).
- Generate monthly and quarterly quality reports for review by senior and executive management, including the input to monthly dashboards, CAPA reviews and Operational or Executive Management Review meetings.
- Generate such data as is required for Dashboard monthly reviews; Act as site EtQ administrator.
- A degree (or equivalent) in a science subject.
- Experience in an appropriate role in a regulated industry.
- Working knowledge of ISO9001, ISO13485 and FDA Quality System Regulations an advantage.
- Well-developed organisational skills with an ability to work independently.
- Lean Manufacturing application / 6 Sigma Green or Black trained would be desirable.
For more information or to apply for this Quality Compliance position, please contact Julie on 01438 723500 or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44981 in all correspondence.