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Remote - Senior Quality Assurance Auditor - Clinical

Blackfield Associates are currently supporting the search for a remote based Senior Quality Assurance Auditor (GCP) to join a leading CRO.


As the Senior Quality Assurance Auditor, you will carry out all assigned responsibilities within the QA department, including conducting audits, document reviews, SOP and process development, non-compliance management, CAPA follow-up, training, QA consultancy internally and externally, and supporting QA and operational process improvement initiatives.



Key responsibilities within the position will be to (Not limited to):



  • Oversee the implementation and appropriate update/improvement of the Quality Management System, including ongoing development and maintenance of QA systems and procedures

  • Produce and manage the Audit Schedule in collaboration with QA Management.

  • Lead on assigned projects within the QA team.

  • Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of procedures.


The ideal candidate will have proven success working in a QA/Quality Management role within a GCP regulatory environment.

You will also have excellent decision-making and problem-solving skills and proven experience in addressing significant non-compliance, including Root Cause Analysis, Corrective and Preventive Action.


If you are interested in this opportunity, please send your up-to-date CV to addison@blackfieldassociates.com or call Addison on 02392 322338.



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