South of Paris, FR: QA Contractor (235194)

Life Sciences & Technology
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Duration:

  • Till end of the year, option to extend at year end

Onsite:

  • 3 days first week onsite, then hybrid and open to mostly remote

Job description:

  • Our client has a need for a GCP/QA Contractor to join the team at their facility just south of Paris. The ideal candidate would have 5+ years of experience and 1+ years of GCP or CQA experience. They would be responsible for assisting with clinical trials, handling basic GCP activities, managing documentation, and a plus would be background or understanding of regulatory authority inspection.

Purpose of the role:

  • Act as the primary clinical quality contact for entities or individuals involved in clinical trials conduct
  • Support and oversee the quality event/ Serious breach management
  • Support and oversee the CAPA management activities
  • Support the inspection readiness activities
  • Support audits activities

Duties and Responsibilities:

Clinical study QA representative

  • For the clinical studies assigned, works with the study team to ensure good clinical practices and compliance to the relevant regulatory requirements are met
  • Participate to project meeting and ensure timely assistance for all quality related topics
  • Participate to service provider selection and quality oversight for the studies assigned
  • Escalate to QA TA Lead identified issues that require further support and assistance

QMS Process

  • Quality Event and Serious Breach
  • Review and approve major/critical Quality Events and potential Serious Breaches
  • Corrective and Preventive Actions (CAPA):
  • Support business functions, and tracking to timely completion, of Corrective and
  • Preventive Actions, contributing to root cause and risk analysis of clinical research matters, and assisting in establishing the effectiveness of implemented CAPA.
  • Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed
  • Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary
    and facilitating Quality Risk Management activities
  • Quality Documents
  • Contribute to the continuous improvement of R&D Quality Documents as assigned
  • Quality Assessments
  • Contribute to the Quality Assessments/Self-Inspection as assigned

Audits and inspections

  • Support inspection readiness activities for high-risk studies:
  • Support sponsor mock inspection, quality assessment activities,
  • Conduct the quality control of study documents
  • Set up regular meetings with Subject Matter Experts (SMEs) (including Service Provider), workstreams per topics to enable successful preparation outputs/deliverables,
  • Monitor progress of the preparation of the inspection and report the risks identified, any remediation actions,
  • Assist in the preparation and conduct of inspection as required.
  • Ensure timely data entry within the eQMS
  • Support the audit activities: provide information to audit group for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis and definition of CAPA.

Training

  • Contribute to training sessions as SME, by reviewing training materials or participating in presentations where needed.
  • Guide system users to ensure they are trained when required (e.g. when a specific training task is required in eLMS)
  • Liaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities.

Experience & Qualifications:

  • Minimum 5 years’ experience in Quality Assurance in the pharmaceutical industry in management of quality system
    including experience at corporate level preferably in Research and Development
  • Language : English

 

South of Paris, FR: QA Contractor (235194)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Europe

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