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Job Details

Senior QA Specialist (GCP)

Company: MSI Group Limited
Location: Amsterdam, Netherlands
Reference: VR/02398
Closing Date: 30 Nov 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

A leading pharmaceutical organisation are urgently looking for a Senior QA Specialist (GCP) to join their team based in Amsterdam, Netherlands on an initial 6-12 month contract (0.8 FTE).

Requirements:

A leading pharmaceutical organisation are urgently looking for a Senior QA Specialist (GCP) to join their team based in Amsterdam, Netherlands on an initial 6-12 month contract (0.8 FTE).

Under the direction of the Head of QA, the Senior QA Specialist GCP is responsible for QA activities that fall under GCP and GVP within the activities of the following department(s) and groups:

  • Clinical Development
  • Clinical Operations
  • Regulatory Affairs
  • Pharmacovigilance

This definition of score is application for all responsibilities below. The Senior QA Specialist GCP takes on the role of QA GCP expert.

  • Contribute to a company culture in which quality management and compliance form a fundamental part of business processes
  • Support and work closely with all areas of Clinical Development in the achievement of the missions and objectives of the department through provision of support as needed for training or consultation
  • Work closely with QA Management and other QA functions to ensure company-wide implementation of the QMS and continuous improvements
  • Create and maintain annual quality plans to ensure QA oversight and support for all areas listed as in scope above, with specific attention to each clinical trial
  • Maintain oversight of deviations (relating to study protocols, SOPs, GCP etc.) and CAPA’s
  • Initiate, and oversee and/or support improvement programs
  • Provide regular reports and update to management
  • Identify trends and/or significant issues and update actions plans based on this information on a regular basis
  • Create and maintain annual audit plans (as part of the annual quality plan)
  • Take on the role of Lead Auditor: Lead of participate in internal / external audits, including audits of processes / systems, vendors, clinical trial sites, documents etc.
  • Ensure audits are performed, reported and followed up according to audit plans and application internal procedures
  • Maintain a tracking system / metrics for Clinical Development audits, findings and Corrective and Preventive Action (CAPA) plans
  • Support the implementation o the client quality manual
  • Perform QA review and sign off for SOPs and other documentation (such as essential documents for clinical trials, where applicable)
  • Help to determine training requirements for staff
  • Support the assessment of SOPs for relevance and training requirements
  • Manage quality programs for clinical development vendors

Qualifications

  • University degree (life sciences preferred)
  • 4+ years of relevant experience in the pharmaceutical industry with good knowledge and understanding of GCP
  • Scientific, technical and regulatory knowledge in the specific areas
  • Auditor training and/or formal qualification
  • Fluent in English, both written and verbal

Apply for this job: Senior QA Specialist (GCP)

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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