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Job Details

Senior QA Exec / Auditor (GCP)

Company: Clinical Professionals Ltd
Location: Cambridgeshire
Reference: J31726
Closing Date: 11 Jan 18
Type: Contract
Salary (£): Negotiable
Benefits: Competitive daily rate

Job Summary:

Senior QA Exec / Auditor (GCP) Clinical Professionals is working with a global pharmaceutical company, that is recognised for its leading position within their drug discovery and development process.

Requirements:

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

Apply for this job: Senior QA Exec / Auditor (GCP)

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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