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.
Responsibilities:
1. Establishes and maintains raw material suppliers, SOPs, and systems.
2. Manages qualification of materials used during the manufacturing process.
3. Ensures appropriate level of qualification for BioAtrium suppliers and service providers.
4. Establishes, maintains, and ensures the correctness of raw material suppliers, data/information within the appropriate quality system (i.e. SAP, TrackWise).
5. Manages change notifications and quality alerts from the company network.
6. Manages deviations and changes associated with suppliers and materials.
7. Collects KPI linked to services associated with materials and suppliers.
8. Ensures the timely escalation of critical quality issues linked to suppliers or materials, while ensuring compliance with GMPs.
Other Requirements:
1. Supports activities related to the qualification of service providers (i.e. audits).
2. Acts as deputy for material release in LIMS.
3. Acts as deputy for special usage decisions of material.
Key Metrics:
1. Timely escalation of all quality issues related to the scope of work.
2. Collect and organize material and supplier-related KPI for Monthly Quality council as per SOP.
3. No overdue quality records within the department.
Key Stakeholders:
1. External: Companies department delivering services linked to supplier and material qualification.
2. Internal: BioAtrium Logistics.
Required Skills:
1. Strong knowledge of GMP regulations and pharmaceutical quality management systems.
2. Knowledge of quality systems, especially SAP and LIMS.
3. Knowledge in managing quality tools, including deviations, CAPA, and change controls.
4. 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).
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