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Job Details

Senior GCP Auditor (UK)

Company: Premier Research
Reference: QA-UK
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Competitive

Job Summary:

Premier Research are a growing global CRO focused on delivering high quality clinical research projects to their diverse client base. With industry leading expertise in Paediatrics, Analgesia, Oncology and CNS we are looking for career focused individuals who want to be a part of our growth


Role: Senior GCP Auditor / QA Auditor 

Contract: Permanent

Location: Home Based OR Office Based (Wokingham)

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a talented and energetic Senior GCP Auditor to join us here in our office in Wokingham, UK. We are also open to home based for this role. 

Here at Premier - instead of trying to be everything to everyone, we focus on doing what we do best, and doing it better than anyone else.

You'll be accountable for:

  • Assist with the maintenance of the global Quality Assurance System
  • Assist in the provision of QA review of SOPs prior to approval
  • Input into the development and maintenance of a global audit strategy and Quality Assurance function
  • Preparation and maintenance of a global audit schedule
  • Organise, lead and participate in contracted audits (investigator sites, trial master files, database, study reports etc.) and internal audits (systems, processes, vendors, computer system validation etc.) across global operations (including preparation of audit plans, audit checklists, audit reports and certificates)
  • Raise significant issues of non-compliance and track CAPAs 
  • Provide training to employees on ICH GCP, FDA regulations and other applicable regulatory standards
  • Manage, host and support sponsor audits and Regulatory Authority inspections
  • Provide a Quality Assurance consultancy service for questions and issues raised by Premier Research personnel
  • Assist Business Development in representing Premier Research services to sponsors

You'll need this to be considered:

  • GCP experience in auditing clinical trials including auditing internal processes and performing vendor audits
  • Ability to interpret research protocols and audit medical records
  • Experience in hosting and responding to regulatory inspections preferred
  • Excellent knowledge, skills and ability in oral and written communication of the English Language. An additional language such as French would be desirable.
  • Ability to be able to professionally interact with internal and external stakeholders regarding Premier Research’s regulated industry, with excellent organisational, interpersonal and communication skills
  • *** For this role we are open to CRAs, Clinical Managers and Project Managers looking to move into QA ***

If you are looking for a career within a transparent and non-hierarchical organisation then please contact us at the email address listed below. We are open minded and flexible regarding the talent we recruit, ultimately we are looking for people who will share in our vision and realise the importance of communication, building relationships and adhering to the highest quality standards.

Please note:- You must be eligible to live and work in the UK in order to apply for this role.

Keywords:- Quality Assurance, QA, QA Auditor, GCP, GCP Auditor, Senior QA Auditor, Quality Assurance Auditor, Auditing, Clinical Auditor, UK, Office Based, Home Based, Permanent, Wokingham, Berkshire, England, CRO, Clinical Research Organisation, Clinical Research, Pharma, Pharmaceutical, Clinical Trials

Apply for this job: Senior GCP Auditor (UK)

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
RG41 2GY
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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