Aktuelle Jobs im Zusammenhang mit Quality Assurance Specialist - St Gallen, Sankt Gallen - CSL Vifor
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Global Supply Chain Specialist
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Global Supply Chain Specialist
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Global Supply Chain Specialist
vor 1 Monat
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Quality Assurance Specialist
vor 2 Monaten
CSL Vifor is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing best QA support for our affiliates and partners.
Key Responsibilities- Ensure inspection readiness of affiliates
- Maintain and improve compliance of the Affiliate Quality Management Systems (QMS) with company policies, industry standards, and local GMP/GDP regulations
- Ensure compliance of local product supply in cooperation with Regulatory, Legal, and other internal and external stakeholders
- Write, review, and manage Quality agreements
- Support for regulatory submissions and variations in close cooperation with global and local stakeholders
- Audit affiliates, partners, and third parties as warehouses, logistic service providers, etc.
- Support affiliates and partners in any launch and supply-related activities
- Create, review, and approve compliance records (Changes, complaints, deviation) and other documents
- Provide an overview about Quality System Performance of affiliates and partners
- Support in training management for affiliate team members
- Bachelor/Master Degree in Life Sciences or related industries or working experience in the pharmaceutical industry
- Minimum 3 years overall experience within the pharmaceutical, biotechnology, or medical device industry
- Experience in Quality Assurance
- Experience in regulatory inspection management and ideally interactions with health authorities
- Experience with software for Quality processes (e.g., Trackwise)
- Strong organizational skills with the ability to manage multiple priorities and timelines
- Team player
- Fluent in English, German, and/or other languages are an asset
- Working experience in different cultures
- Experience in auditing
- Knowledge of different local pharmaceutical legal requirements
- Management of trainings in electronic systems
