Quality Assurance Manager - Europe

Quality Assurance Manager - Europe

Synteract

London, United Kingdom

Position Overview

The Quality Assurance Specialist contributes to Quality Assurance initiatives by developing SOPs and Work Instructions and managing the controlled document process. S/he ensures compliance with applicable regulatory requirements including the setting of QA targets and ensuring compliance with SOP training and utilization. Furthermore, the QA Specialist plans conducts and reports audits. S/he also analyses metrics and CAPA trends and recommends process improvements.

Specific tasks would include:

  • Performs the writing and revision of Standard Operating Procedures (SOPs) and Work Instructions (WI), ensures training sessions are held on new/revised SOPs.
  • Ensures departmental WI reviews are performed per requirements.
  • Ensures SOP training is documented.
  • Supports QA management in training of staff on new versions of controlled documents.
  • Provides external SOP information to sponsors or 3rd party vendors.
  • Gathers, analyzes, and reports QA metrics.
  • Assists with issue resolution and CAPA management.
  • Analyzes trends, recommends process improvements.
  • Provides oversight of QA and Risk Management plans for clinical trials; liaise with PM/CO departments to ensure plans are completed and followed.
  • Performs oversight of feedback questionnaire process.
  • Prepares for external audits conducted by clients, potential corporate partners, or regulatory agencies.
  • Contributes to audit responses.
  • Performs follow up to ensure audit action items are closed.
  • As appropriate, analyzes trends and recommends process improvement possibilities.
  • Coordinates and conducts periodic internal audits.
  • Develops applicable documents and conducts audits related to training documentation, study files, TMF, System, or study-specific spot-check audits).
  • Provides training to local QA Compliance Officers.
  • Assists with maintenance of QA Audit Plan for internal audits.
  • May provide day-to-day guidance and direction to lower level Quality Assurance personnel.
  • Monitors changes in federal regulations and notifies relevant departments of notable changes.
  • As needed, serves as back-up to other QA team members across job functions.

Qualifications

  • Bachelors degree in a related field of study and a minimum 8 years experience, or equivalent combination of studies and relevant work experience inclusive of substantial quality management oversight.
  • Comprehensive knowledge of Quality Management Systems.
  • Advantageous: passed training in QA Systems according to ISO9001.
  • ICH-GCP body of knowledge and the conduct of clinical trials is required.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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