QA Operations Specialist

Grifols, S.A; España; Hybrid; PHP 30,000 - 50,000; Full time

Benefits offered by this job

Permanent position

Job summary

Grifols, S.A. in Romblon, España, is seeking a QA Plasma Operations & Lookback Specialist. This role focuses on controlling the acceptance process for plasma and non-plasma materials, ensuring compliance with various regulations and customer requirements.

The ideal candidate should hold a Bachelor's degree in Health Sciences and have at least 3 years of Pharma Quality experience. The position offers a permanent contract with an afternoon shift and some flexibility to work remotely.

Qualifications

• 3 years of experience within Pharma Quality.
• Knowledge of GMP.
• Basic statistical knowledge.
• Proficiency in MS Office and SAP.
• Advanced level of English.

Responsibilities

• Ensure compliance with plasma unit surveillance processes.
• Evaluate supplier documentation for plasma shipments.
• Manage deviations and collaborate in investigations.
• Analyze data and prepare periodic reports on the process.

Skills

Health Sciences

Pharmaceutical Quality

GMP knowledge

Basic statistics

MS Office proficiency

SAP proficiency

Advanced English

Education

Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry)

Master or Postgraduate degree in the pharmaceutical sector

Job description

Company Overview

Grifols is a global healthcare company with a focus on plasma‑derived medicines and transfusion medicine, operating in more than 110 countries.

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.

Job Title and Mission

QA 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.
  • Manage deviations and collaborate in investigations.
  • Contribute to tasks for release of plasma fractions to customers.
  • Data analysis, filing, and administrative tasks related to intermediate product management.

Qualifications

• Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry); Master or Postgraduate degree in the pharmaceutical sector is valuable.
• 3 years of experience within Pharma Quality.
• Knowledge of GMP.
• Basic statistical knowledge.
• Proficiency in MS Office and SAP.
• Advanced level of English.

Benefits and Schedule

Schedule: Monday to Friday from 14h to 22h (Afternoon shift). Flexibility for U Program: Occasionally remote.

Benefits package: Contract of Employment: Permanent position.

We are an equal opportunity employer.

We believe in diverse talent and welcome you to inform us if adjustments are required during the selection process.