Natasha Young at CK Group is recruiting for a Quality Management System Specialist to join a global medical technology company in the pharmaceutical industry at their site based in Hull a contract basis for 12 months.
Our client is a company that supports healthcare professionals in over 100 countries in an effort to improve the lives of their patients. The company takes a pioneering approach to the design of advanced medical products and services by securing wider access to their diverse technologies for more customers globally and by enabling better outcomes for patients and healthcare systems. They hold leading positions in Orthopaedics Reconstruction, Wound Management and Sports Medicine to name a few.
This role is located on our client's site in central Hull, a short distance away from the A63 and easily commutable by car or public transport.
The Quality Management System Specialist will assist in the development, maintenance and co-ordination of the Quality Management Systems (QMS), supporting the Implementation of changes to Company Global Policies, Regulations and International Standards into the Hull QMS whilst complying with company Quality Systems and applicable Regulations & Standards, Health & Safety Requirements and Site Safety Policy.
Key Responsibilities include:
· Performing all activities in compliance with relevant GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices
· Ensuring that all Quality Systems external communications including customer postal audit responses are of an acceptable standard to meet customer needs and facilitate improvement where necessary
· Assisting and support the internal audit schedule in accordance with the procedure, to ensure compliance and timely close out of improvement actions
· Supporting the integration of Global Policies and updated Regulatory & International standards requirements into the Hull Quality Systems.
· Supporting Change Control activities ensuring outputs are correctly translated into procedures
· Managing Corrective Action & Preventative Action (CAPA) and escalate adverse trends and ensure all specified actions are closed in a timely manner
· Collating, interpreting and reporting data from multiple sources to support business reporting activities
To succeed in this role, you will be educated to degree level or has equivalent work experience in relevant area, have an understanding of the Medical Device Directive, GMP, GDP, ISO 9001, ISO 13485, 21 CFR Part 820 as well as knowledge of of the potential for product liability, alleged adverse incidents and potential Field Safety Corrective Actions.
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 KA43907 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Natasha Young
- Phone: 01246 457722
- Reference: KA43907
- Posted: 9th November 2018
- Expires: 7th December 2018