Company OverviewGrifols is a global healthcare company with a focus on plasma‑derived medicines and transfusion medicine, operating in more than 110 countries.
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Job Title and MissionQA Plasma Operations & Lookback Specialist
The role's mission is to control and oversee the acceptance process for plasma and non‑plasma raw materials, ensuring compliance with legal, regulatory and customer requirements.
Responsibilities
- Surveillance Process for Plasma Units
- Ensure that the surveillance of plasma units alerted as post‑donation information is handled according to the approved procedures.
- Ensure compliance with the established deadlines for managing alerts.
- Analyze the causes that give rise to communications and inform Technical Management when necessary.
- Evaluate the potential risk of plasma batches.
- Analyze data and prepare periodic reports on the process.
- Other administrative tasks related to plasma surveillance.
- Acceptance Process for Raw Materials
- Evaluate supplier documentation for plasma shipments and fractions against approved requirements.
- Assess maintenance of the cold chain during transportation per specifications.
- Report and verify results of raw material acceptance per inspection plans, deciding on use of shipments.
- Manage discrepancies and potential deviations with suppliers.
- Establish and maintain guidelines for purchasing and evaluating quality‑subjected suppliers, advising Purchasing Section coordination.
- Data analysis, filing and administrative tasks related to raw materials process.
- Coordinate workflows within the lifecycle of plasma fractions to ensure availability within timelines.
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