QA Operations Specialist

Grifols; Parets del Vallès; Híbrido; EUR 35.000 - 50.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Permanent position

Occasionally remote

Descripción de la vacante

Grifols is seeking a QA Plasma Operations & Lookback Specialist in Parets del Vallès, Spain. You will control the acceptance process for plasma and non-plasma raw materials, ensuring compliance with legal and regulatory requirements.

The role requires a Bachelor’s degree in Health Sciences and at least 3 years of experience in Pharma Quality. Proficiency in English and knowledge of GMP is essential. Occasional remote work is available.

Formación

• Bachelor's degree in Health Sciences required.
• Minimum 3 years of experience in Pharma Quality.
• Advanced level of English is necessary.

Responsabilidades

• Coordinate the surveillance process for plasma units.
• Ensure compliance with established deadlines.
• Evaluate the potential risk of plasma batches.
• Analyze data and prepare periodic reports.
• Manage discrepancies and potential deviations.

Conocimientos

GMP knowledge

Statistical analysis

MS Office proficiency

SAP knowledge

Advanced English

Educación

Bachelor's degree in Health Sciences

Master’s degree in pharmaceutical sector

Descripción del empleo

Grifols is a global 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