Fantastic opportunity within a leading CRO for an experienced Clinical QA Auditor to shine and be rewarded! Field Based or Office Based in Berkshire
A senior level clinical QA role with our client, a renowned and very personable clinical research organisation who started operations in 1994 with the premise of delivering cost-effective, quick-to-market clinical services in the emerging markets of Central and Eastern Europe. Since then, an expansion of services to more than 40^countries, including: North America, Western Europe, Central & Eastern Europe, Latin America, India, and South Africa.
The Primary goal of this role is to assist with the development and maintenance of audit programmes ,internal and external, as part of the Quality Assurance program within clients Group of companies.
Responsible for scheduling and conducting study related audits to support sponsors.
To support operations by auditing vendors, conducting systems audits and providing advice to support operations.
To provide a key role in assisting operations during Sponsor audits and Regulatory inspections.
To act as primary QA representative for assigned projects.
As a senior member of the group, assisting the Director of Global QA, in mentoring auditors, reviewing audit reports and recommending improvement strategies.
Essential Skills & Qualification
Minimum qualification of a life sciences degree/nursing qualification or appropriate previous work experience
Minimum experience of 5 years in a GCP environment, with at least 3 years as a CQA Auditor.
A thorough knowledge of ICH GCP and relevant European Directives/FDA guidelines and other national guidelines/regulations.
Excellent communication^and interpersonal skills.
Attention to detail.
Software Competence: MS Office, MS Project, Zinc, DOCUMENTUM
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: Yes
Employment Type: Permanent
Hours: Full time
Location: Location Independent or Berkshire, Home Based/Office Based
Plan Start Date: 30th July 2012
Company Pension, Car Allowance, Life Insurance, Private Healthcare Package Plan, Bonus, Childcare Vouchers. Relocation Assistance.
MS Office, MS Project, DOCUMENTUM
Clinical Research, Clinical Operations, EUCTD, ICH GCP, Essential Documents,^GCP, SOPs, Compliance
Quality Assurance, Audit, Inspection, GCP,Clinical QA, Auditor, GCP Inspection, PVG Inspection
Assigned Consultant: Sue Spice at CSL Recruitment on
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.