30 jul
|
Grifols
|
Madrid
Grifols is a integral healthcare company that has been working since 1909 to improve health and well‑being worldwide. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines and services in more than 110 countries.
Equal Employment Opportunity Grifols is an equal‑to‑opportunity employer and is committed to fostering an inclusive environment. Adjustments can be made for applicants with disabilities.
Position Overview The QA Plasma Operations & Lookback Specialist will control and oversee the acceptance process for plasma and non‑plasma raw materials in accordance with established specifications to ensure compliance with legal, regulatory and customer requirements.
Responsibilities
Coordinate the surveillance process for plasma units
Ensure that the surveillance of plasma units alerted as post‑donation information are handled according to the approved procedures
Ensure compliance with the established deadlines in the management of alerts
Analyze the causes that give rise to communications and inform the Technical Management when the reason requires it
Evaluate the potential risk of plasma batches
Analyze the data and prepare periodic reports on the process
Other administrative tasks related to the plasma surveillance
Control the acceptance process for raw materials
Evaluate the supplier documentation associated with the receipt of plasma shipments and plasma fractions against the approved requirements
Assess the maintenance of the cold chain during transportation in accordance with the specifications
Report and verify the results of the acceptance of plasma materials according to the approved inspection plans, making decisions regarding the use of the associated shipments
Manage discrepancies and potential deviations in the process with plasma suppliers
Establish and maintain guidelines to be followed in the purchasing and evaluation process of quality‑subjected suppliers, advising the coordination carried out by the Purchasing Section
Data analysis, filing and administrative tasks related to the raw materials process
Coordinate the workflows within the lifecycle of plasma fractions to ensure their availability within the established timelines
Manage any deviations that occur and collaborate in the investigations that arise
Contribute to the necessary tasks for the release of plasma fractions to customers
Data analysis, filing, and administrative tasks related to the management process of intermediate products
Qualifications
Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry); a Master’s or postgraduate degree in the pharmaceutical sector is valuable
3 years of experience within Pharma Quality
Knowledge in GMP
Basic statistical knowledge
Proficiency with MS Office and SAP
Advanced level of English
Schedule Monday to Friday, 14:00–22:00 (afternoon shift)
Benefits Package
Permanent position
Occasionally remote
Location: Parets del Vallès, Spain
📌 QA Operations Specialist (Madrid)
🏢 Grifols
📍 Madrid