SENIOR QA SPECIALIST | YORK | Competitive Salary
A global medical organisation are currently recruiting for a Senior QA Specialist to join their team based in the York area on a permanent basis.
The core function of the role will be to promote and support a culture of audit readiness, oversee GCP and GLP activities and support generation of Key Quality Performance Indicators for the company's Quality Systems.
The key responsibilities are as follows:

• Ensuring the Quality System/personnel is efficient for the business while maintaining compliance


• Lead the development and implementation of Quality Improvement Projects


• Develop, implement and maintain auditing strategies


• Conduct all types of QA required audits, including process, facility, SOP, CSV and study audits as required


• Aid in introducing systems to comply with any revised GLP, GCP, EMA, FDA and OECD guidelines


• Provide support/host customer-initiated audits, mock regulatory inspections and regulatory facility inspections


• Participate in review of root cause analysis, CAPA plans for internal, 3rd party and vendor audits

To be considered for the role candidates must have a minimum of 3 years experience in a laboratory, pharmaceutical, medical device, or clinical research organisation.
Knowledge and demonstrated experience in GCP, ISO 15189, NEQAS, CAP and CLIA would be highly advantageous and a certified Quality Auditor would be preferred.
In order to apply for this role please forward your CV to melissa@blackfieldassociates.com or call Melissa on +44 (0) 2392 322 306 for further details.

STR Limited is acting as an Employment Agency in relation to this vacancy.