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Clinical Quality Assurance Manager

Website Achieva Group Limited

Senior Clinical Quality Assurance  Manager 
Work Location: Basel 
Duration: 12 months
Contractor Rate: CHF 69/hr – CHF 86/hr

Provide expertise / support for Organisation Clinical Trials:

  • To represent CQA for organisations Clinical Trials
  • To work closely with organisation, CRO Clinical Trial Teams during the preparation, execution, and closure of Organisation clinical trials
  • To develop own area of clinical trial expertise with limited supervision 
  • To ensure Organisation, CRO Clinical Trial Teams stay compliant with regulatory requirements 
  • To influence and convince Organisation CRO Clinical Trial Teams to implement robust clinical trial processes / systems.
  • To escalate serious or continuing non-compliance GxP issues as appropriate.
  • To organize trainings on clinical trial requirements (e.g., ICH-GCP refresher)
  • To present ICH-GCP important topics (e.g., CQA audit finding, GCP inspection)
  • To contribute to training / mentoring other CQA colleagues Quality Systems
  • To manage Quality System documents (e.g., SOP, WIS) creation and management and to ensure it is done in accordance with clinical trial requirements.
  • To manage and lead process improvements
  • To develop and improve CQA tools and processes.
  • To develop and improve clinical trial electronic systems (e.g., Quality Event Module, clinical trial systems)
  • To help with trouble shooting for Organisation processes and systems GCP Inspection
  • To lead and manage the preparation, facilitation and follow up of inspections by international regulatory authorities.
  • To lead and manage GCP inspection CAPAs elaboration, approval and follow-up CQA Audit for CQA manager expected to be also an Auditor as defined in Organisation SOP-101134:
  • To work as per the defined strategy for the global clinical audit program (e.g., site, vendor, process)
  • To plan, perform, and report standards and/or complex audits (e.g., site, vendor, process) at the global level.
  • To lead and manage CAPAs elaboration, follow-up and closure.

REQUIRED QUALIFICATIONS AND EXPERIENCE

  • At least a bachelor’s degree or equivalent education/degree in (life) sciences or healthcare
  • Experienced in Clinical Research & Development.
  • Good knowledge of clinical trial regulatory requirements and pharmaceutical industry practices – particularly ICH-GCP
  • At least 6 years of experience within pharmaceutical industry/health authority with at least 3 years ‘experience in Quality Assurance (QA) within the ICH-GCP environment.
  • Knowledge of electronic tools used in clinical trials (e.g., eTMF, ePRO, eSource)
  • Reliable, conscientious, agile/flexible, open-minded
  • Very good risk analysis and problem-solving skills
  • Very good negotiation skills
  • Very good writing, verbal and listening skills
  • Ability to work as a team player and independently
  • Experience working in international cross-cultural relations
  • For Senior CQA manager expected to be also an Auditor as per defined in Organisation SOP-101134: ability to travel at least 25% of the time

For further details, please contact Rudo Urayayi on +44(0)1727 817 616 or email a copy of your CV to rurayayi@achieva.co.uk

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