Senior QA Officer

Recruiter
Clinical Professionals
Location
London (Greater)
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
Senior QA Officer / Senior QA Executive
Type: Contract
Daily Rate: Competitive
Location - Cambridgeshire

Clinical Professionals is working with a global pharma company, that is recognized 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.
* 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