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Job Details

Quality Manager - Alsace, France

Company: CellProthera
Location: Alsace, France
Reference: QM001
Closing Date: 02 Feb 19
Type: Full Time
Salary (£): Competitive
Benefits: Excellent

Job Summary:

CellProthera is a biotech company based in France (Alsace) developing innovative cell therapy products (ATMP) based on a proprietary bioprocessing technology. A multi-center Phase I/IIb clinical trial is currently on-going in Europe for the treatment of Acute Myocardial Infarct patients. A safety trial has also recently started in Singapore. We are looking for an experienced Quality Manager to support and develop the implementation of the overall quality system and compliance programs.

Requirements:

Your Mission

  • Provide a QA oversight on external suppliers from supplier qualifications, changes in supplier, to quality agreements, in close collaboration with department leaders.
  • Write and update Standards Operating Procedures and QMS documentation in compliance with cGMP standards and ensure implementation at third parties
  • Manage deviations, change controls and CAPAs and report monthly KPIs
  • Contribute to Internal and External Audits program
  • Deliver Quality related Training, ensure that Quality Policies are applied across the company and that employees’ qualifications are up-to-date.
  • Assist department leaders in the execution and implementation of ad-hoc projects

 

Your Profile

  • Bachelor's Degree/equivalent in scientific discipline, ideally in Pharmaceutical, Biotech-, Chemical- or Biological sciences
  • Min. 3 years-experience in a Pharma QA/QC GMP environment.
  • Quality Assurance qualifications and working knowledge of cGMPs. Knowledge of GMP for ATMPs is a plus.
  • Rigorous, result-oriented, hands-on and autonomous.
  • Strong communication and teamwork skills
  • Fluency in English. French conversational

 

Applicants should be entitled to work within the European Economic Area (EEA).

 

Apply for this job: Quality Manager - Alsace, France

Contact Information:

Address:  Head Office
12 Rue du Parc – 68100 MULHOUSE – FRANCE

France
Website:  Visit Our Web Site

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