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Quality Assurance Manager

Quality Assurance Manager

CHF 130'000
REF: 3157G
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As Quality Assurance Manager you will oversee quality assurance activities and support GDP and GMP activities to ensure product quality all the way to the patient. You will manage specific projects related to Product distribution and improvement of standards and compliance.

Quality Assurance Manager
 

Stellenbeschreibung

Provide quality assurance operational support and supervision in Affiliate markets and provide guidance to local quality responsible to ensure compliant quality management system.

Hold regular Quality Management Reviews with affiliates to monitor appropriateness of quality systems and processes to meet requirements and any changes that may impact processes and licenses. Support license changes and applications when required and monitor changes which may impact current licenses. Support regulatory inspection readiness, coordination and follow-up with appropriate functions. Collaborate with Internal and External Audit, R&D, PO&T and GTO functions to support audits and facilitate remediation of audit findings. Support any recall activities as per definition of recall committee. Minimize backorder situations. Approve exceptional in-country repackaging activities.

 

Launch of New Products – QA set up for distribution. Oversee transport and cold chain set up. Define requirements for customer qualification and define requirements for virtual QA release Job

QA Lead for Commercial Product Distribution Program: Support process of distribution network changes for QA

Product serialization: QA support for serialization set up.

Qualifications

  • Min. 10 years of GMP or GDP experience for Medicinal Products
  • Quality and Logistics experience
  • Proficiency in English, German and French are an asset
  • Thorough understanding of regulations on Good Manufacturing Practices and Good Distribution Practices
  • Knowledge of medical/biological and cold chain products
  • Leadership
  • Appropriate level communication skills
  • Capacity to manage conflicts and solve problems
  • Working knowledge in ISO Requirements / Certification Process
  • Flexible when priorities change

 

If you are interested in this specific opportunity, please feel free to reach out to us and send us your full documents, indicating the reference 3157G.

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