Quality Assurance Officer

Real Resourcing
South East England
12 Jan 2018
11 Feb 2018
Contract Type
Full Time
I am partnering an SME specialising in Medical Imaging and its associated services to find both an influential Quality Assurance Officer to support the Quality Assurance Manager with the company's Quality standards, systems and processes to ensure compliance to GCP & ISO 13485. The role is based in Central London and paying circa £45k.

The role will lead in performing Audits and Quality Investigations to ensure audit readiness. The role will also co-ordinate process and training reviews to enhance business effectiveness. There is a particular focus on maintaining an electronic Project File to assure the data the company provides to sponsors for their Trial Master File. Additional oversight is required for the validation of computer systems, ensuring data is properly de-identified, data transfer to sponsors and electronic audit trails as well as training clinical sites

The organisation is strongly backed and growing exponentially and is founded by some of the world's leading scientists.

Key Responsibilities:

* To ensure quality compliance against Good Clinical Practice (GCP), clinical trials regulations and MDD expectations; e.g., EU Directives, CFR 21 Parts 11 and 312 as well as ISO 9001, ISO 13485, ISO 14971, MDD 93/42 EEC and Data Protection legislation.
* Ensuring the electronic Quality Management System (QMS) is maintained and procedural updates happen by the cycle review date
* Co-ordinate two way facilitation regarding Quality Plans business wide
* Track and manage CAPAs, dealing with them in a timely manner and conduct Quality investigations
* Support implementation of Corrective Actions and/or Preventive Actions
* Support on customer audit and notified body inspection preparations
* Host and manage audits by current customer base and potential customers
* Provide induction training for all new starters
* Provide GCP and ISO expertise, guidance and training as required

Skills and Experience:

* Experience in Quality Assurance within in the Medical Device and/or pharmaceutical regulatory environment or running trials in a University or hospital setting
* Experience of ISO 13485 Quality Management Systems
* Working knowledge of defining and maintaining Quality Management Systems
* In-depth understanding of GCP and associated regulations

If this is something you would like to further explore, apply now!

Sthree UK is acting as an Employment Agency in relation to this vacancy.