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Job Details

**Clinical Quality Assurance Auditor - Cambridge**

Company: Advanced Clinical Recruitment Ltd
Location: Cambridge
Reference: QA-CQA
Closing Date: 15 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary + Package

Job Summary:

I am currently working with a very interesting and exciting traditional Pharmaceutical company, based in Cambridge, who are actively seeking a Clinical Quality Assurance Auditor to join their team! This professional will have specific expertise in the planning, conduct and follow up of GCP Quality Audits as well as specific working knowledge across GCP in the Quality field. This role is perfect for a professional coming from a CRO or smaller pharma background, looking to progress.

Requirements:

The CQA Auditor is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The QA Auditor is independent of the Clinical Research Team.

 

Responsibilities:

  • Plan, prepare and conduct trial specific, quality system, and vendor qualification audits and report findings to the auditees
  • Create QA SOPs required for the proper functioning of the clinical trial process
  • Act as Quality Project Lead (QPL) on assigned studies, ensuring quality related oversight of projects and to act as a QA point of contact for study team members
  • Audit the quality of the clinical trial against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and address the issue immediately with the Project Manager; and if required, with Senior Management
  • Provide regular feedback to the QA Audit Management team about the quality standards practiced in the company and give recommendations for their improvement
  • Provide support and advice to other departments for quality improvement
  • Conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner
  • Provide GCP/GMP consultancy and advice in response to questions raised by individuals from the organization
  • Actively participate in training sessions and workshops, including presenting reports from any conferences attended
  • Ensure timely completion and documentation of all training requirements
  • Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations
  • Be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance
  • Other duties, as required by the Quality Assurance department 
     

Profile:   

  • A university degree in a biomedical or related life science, nursing or engineering qualification is beneficial
  • Minimum 5+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • At least 2 years of auditing experience within a Clinical Research or Pharmaceutical environment is mandatory
  • Diplomatic and professional oral and written communication skills to be able to convey and discuss audit findings, good organisational skills and personal presentation
  • Methodical and meticulous, with excellent attention to detail
  • Ability to proactively manage multiple responsibilities and tasks
  • Experience working in a team environment under time and resource pressures
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
  • Ability to review data and procedures in detail and the ability to see the greater overall perspective Understanding of the principles of ICH-GCP and all applicable regulatory requirements
  • Ability to guide, supervise and motivate less experienced staff
  • Ability to train junior members of the QA Compliance team on relevant QA systems, processes and procedures
  • Ability to maintain confidentiality of employee data and information during interactions with staff at all levels Experience and success, working in a busy team environment under time pressure
  • Must be fluent in the English language (written & spoken), additional languages are of advantage

 

Additional:

  • This role is office based in Cambridge
  • Moderate travel availability across Europe is a prerequisite
  • Overnight stays may be required

 

 

For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!

 

Sam Caley - Advanced Clinical Recruitment

+44 (0) 114 270 1741

scaley@acr-uk.com           

LinkedIn Search: Sam Caley Quality Assurance

 

Keywords: QA, Quality Assurance, GCP, GxP, GMP, GLP, Good Clinical Practice, Auditor, Audit, GCP Audits, Clinical Quality Assurance, Lead Auditor, Head or Quality, Senior Auditor, Senior Manager, Management, Audit Strategy, Structure, Home Based, Field Based, Pharmaceutical, Jobs in Pharma, Pharmaceutics, Generics, Specials, CRO, CQA, GCP Auditor

 

Apply for this job: **Clinical Quality Assurance Auditor - Cambridge**

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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