Senior QA Exec / Auditor (GCP)

Expiring today

Recruiter
Clinical Professionals Ltd
Location
East Horsley
Posted
31 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior QA Exec / Auditor (GCP) Location: Cambridgeshire Type: Contract Daily Rate: Competitive Clinical Professionals is working with a global pharmaceutical company, that is recognised for its leading position within their drug discovery and development process. Due to an increase in work demand, our client is currently seeking a Senior QA Officer/ Executive, with a strong background in GCP, for a long term contract. Role Responsibilities: * To Support the process of clinical quality assurance audits from preparation stage. * Follow-up of independent clinical quality assurance audits, * To ensure that clinical trials are conducted in compliance with the relevant GxP guidelines. * To ensure that clinical trials are in compliance with standard operating procedures (SOPs). * To identify process improvement opportunities * To support regulatory inspections including investigator sites and vendor sites * Review of Trial Master Files (TMFs). * To assist the QA team with the implementation and conduct of the QA audit programme. * Conduct, review and monitor the implementation of CAPAs * Prepare for inspection readiness, investigator inspections and external audits * Assist with the development and maintenance of company GxPs and quality standards Requirements: * A degree or equivalent in life sciences * At least 2-3 years of experience in QA within GCP * Strong QMS GCP experience * Excellent experience in supporting the audit process within clinical research * Good knowledge of GCP international regulations * Excellent interpersonal and communication skills Quality Assurance, QMS, GCP, Good Clinical Practice, clinical trials, GxP, Pharma, audit, inspection readiness, Trial Master Files, TMF, CAPA, drug discovery, clinical research

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