QA Operations Specialist (Parets)

QA Operations Specialist (Parets)

04 ago
|
Grifols
|
Parets

04 ago

Grifols

Parets

ppGrifols is a general 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. /p h3Equal Employment Opportunity /h3 pGrifols is an equal‑to‑opportunity employer and is committed to fostering an inclusive environment. Adjustments can be made for applicants with disabilities. /p h3Position Overview /h3 pThe 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. /p h3Responsibilities /h3 ul liCoordinate the surveillance process for plasma units /li liEnsure that the surveillance of plasma units alerted as post‑donation information are handled according to the approved procedures /li liEnsure compliance with the established deadlines in the management of alerts /li liAnalyze the causes that give rise to communications and inform the Technical Management when the reason requires it /li liEvaluate the potential risk of plasma batches /li liAnalyze the data and prepare periodic reports on the process /li liOther administrative tasks related to the plasma surveillance /li liControl the acceptance process for raw materials /li liEvaluate the supplier documentation associated with the receipt of plasma shipments and plasma fractions against the approved requirements /li liAssess the maintenance of the cold chain during transportation in accordance with the specifications /li liReport 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 /li liManage discrepancies and potential deviations in the process with plasma suppliers /li liEstablish 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 /li liData analysis, filing and administrative tasks related to the raw materials process /li liCoordinate the workflows within the lifecycle of plasma fractions to ensure their availability within the established timelines /li liManage any deviations that occur and collaborate in the investigations that arise /li liContribute to the necessary tasks for the release of plasma fractions to customers /li liData analysis, filing, and administrative tasks related to the management process of intermediate products /li /ul h3Qualifications /h3 ul liBachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry); a Master’s or postgraduate degree in the pharmaceutical sector is valuable /li li3 years of experience within Pharma Quality /li liKnowledge in GMP /li liBasic statistical knowledge /li liProficiency with MS Office and SAP /li liAdvanced level of English /li /ul h3Schedule /h3 pMonday to Friday, 14:00–22:00 (afternoon shift) /p h3Benefits Package /h3 ul liPermanent position /li liOccasionally remote /li liLocation: Parets del Vallès, Spain /li /ul /p #J-18808-Ljbffr

📌 QA Operations Specialist (Parets)
🏢 Grifols
📍 Parets

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