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Quality Assurance Manager

Jobs-Pharma

 
Nordwestschweiz (AG/BL/BS/SO)
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Quality Assurance Manager
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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