14 days ago on proclinical.com

CH - Quality Project Manager - Normal

ProClinical AG

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CH - Quality Project Manager - Normal

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Quality Project Manager based in Switzerland. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries. The Quality Specialist will be the Subject Matter Expert and support all system, process, procedures for End to End multi-variant readiness across all systems, BU and worldwide sites.

Key responsibilities

  •  Liaise with all key stakeholders in building and executing on the Multi-variant readiness.
  • Work directly with the Plant Quality Managers at the sites in the Company network to prepare and execute variant introduction.
  • Support process and technology mapping related.
  • Deliver mitigated risk assessment across business (PFMEA).
  • Implement mitigations and assess control of the solutions.
  • Organize and conduct system validations across business.
  • Change / Update procedures as required with other work streams.
  • Prepare and execute system testing plan
  • Understand dependencies across work stream for change impact.
  • Identify critical path and risks to project timeline.
  • Issue status reports and effectively communicate to upper management.
  • Work closely to support all testing.
  • Update the full-scale End to End Business quality related flow and associated communication documents.
  • Highly reliable; delivers to promise, anticipates issues and overcomes emerging hurdles proactively Quantify the resources needed to achieve work stream project goals.

 Education and Experience

  • University/Bachelor’s Degree or Equivalent in a Life Science, Engineering, or Physical Science discipline.
  • 3+ years of relevant experience.
  • Fluent working in English. German or Italian are a plus.
  • Experience in Risk Management, Process Mapping & PFMEAs
  • Operational Equipment qualification and/or CSV validation experience
  • Previous proven Quality experience on large scale enterprises on medical devices requirements and compliance knowledge
  • GMP, GDP, ISO 13485, CFR 820
  • FMEA / Risk approach/ Mapping experience
  • Excellent cultural awareness.
  • Supply chain experience in medical device or pharmaceutical industry

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.