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Job Details

**GCP Quality Professional - Paris - Contract role - Variable Length**

Company: Advanced Clinical Recruitment Ltd
Location: Paris
Reference: QA-Freelance-GCP
Closing Date: 30 Dec 16
Type: Contract
Salary (£): Competitive
Benefits: Contract - Daily or Hourly Rate

Job Summary:

I am currently working with a very interesting and exciting Global organisation who are looking to add a GCP Quality Contractor to the team based in Paris. The company have been through significant positive change, and have moved through a couple of acquisitions, so it is a very exciting time to join. The role requires a GCP quality professional, ideally with operational experience within Clinical. Auditing responsibility would be minimal, and therefore very little travel will be required.

Requirements:

Key Tasks:

  • Coordinate and support functional/clinical trial teams in audit/inspection activities in close collaboration with Clinical Quality Assurance
  • Provide guidance to functional/clinical trial teams and participate in the root-cause analysis to develop CAPA to address audit/inspection findings
  • Work with functional/clinical trial teams to ensure consistent approach/response to audit/inspection findings across clinical trials and programs
  • Track and monitor the CAPA status to ensure timely completion and close-out of CAPAs
  • Identify audit/inspection findings which warrant improvement of functional processes, and support in the development of solutions to maintain compliance
  • Review audit and inspection reports to identify training needs and communicate those needs to those responsible for training
  • Provide guidance on regulations, GCP and other guidelines to functional/clinical trial and program teams
  • Participate in process improvement initiatives
  • Regularly review processes relating to clinical operations in collaboration with line function heads to ensure effectiveness and efficiency of processes, and compliance with regulations, guidelines, Quality Modules and Policies
  • Coordinates or takes part, as necessary, in the maintenance and updating of SOPs, work instructions and forms/templates authored by the Clinical Operations group


Requirements:

  • Bachelor’s degree or equivalent qualification in life science/healthcare, Master degree is preferred
  • Fluent English (oral and written)
  • Thorough knowledge of Good Clinical Practice, regulatory guidelines (FDA/EMA/ICH), and clinical development process
  • At least 3 years clinical/industry/health authority experience, including at least 2 years with focus on quality and compliance in the areas of clinical operations preferred
  • Able to set global quality standards together with team
  • Excellent communications, negotiation and leadership skills
  • Quality focused and attention to details
  • Experienced in designing or re-designing functional processes to meet quality standards and to simplify the way we work
  • Ability to work both independently and collaboratively in global organizations
  • Effective project management and team facilitation skills

 

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, Manager, GCP Manager, London, Remote, Flexible, Central, PV, PVG, GvP, Compliance

Apply for this job: **GCP Quality Professional - Paris - Contract role - Variable Length**

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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