Supplier & Material Qualification Senior Specialist
Lieu de travail Visp
Secteurs Autre
Type d'emploi contrat
Un salaire Negotiable
Référence BBBH609685
Description:
The Supplier & Material Qualification Specialist III, ensures that BioAtrium's suppliers and 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 Shareholders regarding supplier and material qualification.
Additionally, the role ensures that all suppliers and raw material data and information is maintained up to date within the appropriate system, KPI associated to the scope of the role are collected and organized, while also timely escalating risks and issues.
* Establishes and maintains raw material suppliers, SOPs, and systems.
* Manages qualification of materials used during the manufacturing process.
* Ensures appropriate level of qualification for BioAtrium suppliers and service providers.
* Establishes, maintains, and ensure the correctness of raw material suppliers, data/information within the appropriate quality system (i.e. SAP, TrackWise)
* Manages change notifications and quality Alerts from the company Network
* Manages deviations and changes associated to Suppliers and material
* Collect KPI linked to services associated to material and suppliers
* Ensure the timely escalation of critical quality issues linked to supplier or material, while ensuring compliance with GMPs.
Other requirements:
* Supports activities related to the qualification of service providers (i.e. audits)
* Acts as deputy for material release in LIMS
* Acts as deputy for special usage decisions of material
Key metrics:
* Timely escalation of all quality issues related to scope of work.
* Collect and organize Material and supplier related KPI for Monthly Quality council as per SOP.
* No Overdue quality records within department
Key Stakeholders:
* External: Companies department delivering services linked to supplier and material qualification
* Internal: BioAtrium Logistic
Required Skills:
* Strong knowledge of GMP regulations and pharmaceutical quality management systems.
* Knowledge of quality systems, especially SAP and LIMS
* Knowledge in managing quality tools, including deviations, CAPA and change controls.
* Problem-solving and decision-making skills, especially in high-pressure environments.
Education:
Required - Bachelors in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields
Preferred- Masters in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields
Language:
English Fluent, German Preferred
Related work Experience:
Material and supplier qualification (3+ years)
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 Shareholders regarding supplier and material qualification.
Additionally, the role ensures that all suppliers and raw material data and information is maintained up to date within the appropriate system, KPI associated to the scope of the role are collected and organized, while also timely escalating risks and issues.
* Establishes and maintains raw material suppliers, SOPs, and systems.
* Manages qualification of materials used during the manufacturing process.
* Ensures appropriate level of qualification for BioAtrium suppliers and service providers.
* Establishes, maintains, and ensure the correctness of raw material suppliers, data/information within the appropriate quality system (i.e. SAP, TrackWise)
* Manages change notifications and quality Alerts from the company Network
* Manages deviations and changes associated to Suppliers and material
* Collect KPI linked to services associated to material and suppliers
* Ensure the timely escalation of critical quality issues linked to supplier or material, while ensuring compliance with GMPs.
Other requirements:
* Supports activities related to the qualification of service providers (i.e. audits)
* Acts as deputy for material release in LIMS
* Acts as deputy for special usage decisions of material
Key metrics:
* Timely escalation of all quality issues related to scope of work.
* Collect and organize Material and supplier related KPI for Monthly Quality council as per SOP.
* No Overdue quality records within department
Key Stakeholders:
* External: Companies department delivering services linked to supplier and material qualification
* Internal: BioAtrium Logistic
Required Skills:
* Strong knowledge of GMP regulations and pharmaceutical quality management systems.
* Knowledge of quality systems, especially SAP and LIMS
* Knowledge in managing quality tools, including deviations, CAPA and change controls.
* Problem-solving and decision-making skills, especially in high-pressure environments.
Education:
Required - Bachelors in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields
Preferred- Masters in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related fields
Language:
English Fluent, German Preferred
Related work Experience:
Material and supplier qualification (3+ years)
