Languages:
English - fluent; German - advantageous
Overview:
The QA Logistic Specialist, ensures material incoming verification and that BioAtrium's materials qualification process and services associated, are aligned with regulatory requirements corporate standards and agreements in place with shareholders.
This role is responsible for the oversight and compliance regarding the requirements set out in the respective agreement related to the services provided by the Shareholder regarding material receipt.
Additionally, the role ensures that all raw material data and information are maintained up to date within the appropriate system, KPI associated with the scope of the role are collected and organized, while also timely escalating risks and issues.
Key Responsibilities
- Performs incoming material verification according to applicable procedures
- Establishes and maintains raw material suppliers, SOPs, and systems.
- Manages qualification of materials used during manufacturing process including physical verification of incoming raw material and subsequent release in LIMS.
- Manages change notifications and quality Alerts from Lonza Network and raw material suppliers
- Manages deviations and changes associated with material
- Collect KPI linked to services associated with material qualification and release
- Ensure the timely escalation of critical quality issues linked to material, while ensuring compliance with GMPs.
Qualifications
- Performs incoming material verification according to applicable procedures
- Establishes and maintains raw material suppliers, SOPs, and systems.
- Manages qualification of materials used during manufacturing process including physical verification of incoming raw material and subsequent release in LIMS.
- Manages change notifications and quality Alerts from Lonza Network and raw material suppliers
- Manages deviations and changes associated with material
- Collect KPI linked to services associated with material qualification and release
- Ensure the timely escalation of critical quality issues linked to material, while ensuring compliance with GMPs.
- Candidates must hold a valid Swiss work permit or Swiss/EU passport
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QA Logistic Specialist Arbeitgeber: Real
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