QA Specialist – Qualification & Aseptic Operations | Pharmaceutical Manufacturing

Location: Madrid, Spain - onsite

Are you an expert in qualification and aseptic operations?

We are seeking a pro-active QA Specialist to ensure the highest standards of compliance, product integrity, and operational excellence at our new state-of-the-art facility.

Responsibilities:

- Review and approve qualification/validation documents for equipment, utilities, HVAC, water, and production areas.
- Maintain compliance with EU Annex 1, aseptic techniques, cleanroom behavior, and contamination control best practices.
- Provide QA oversight for commissioning, qualification, and validation (CQV) activities.
- Evaluate deviations, CAPAs, and change controls—supporting thorough investigations and root-cause analysis.
- Participate in GMP walkthroughs, on-site quality checks, and aseptic observations.
- Act as a key QA partner for engineering,



production, microbiology, and validation teams—driving qualification excellence.
- Champion data integrity and continuous improvement initiatives for sterile manufacturing.
- Deliver training and guidance on aseptic behavior and EU Annex 1 expectations.

Requirements:

- Bachelor’s or higher in Pharmacy, Life Sciences, Engineering, or a related field.
- 3+ years’ QA experience in GMP pharma, with strong background in qualification/validation and sterile environments.
- Deep understanding of EU Annex 1 and aseptic operations.
- Excellent communicator, detail-oriented, and fluent in Spanish and English.

Join us and make your mark by advancing quality and safety in pharmaceuticals!

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📌 Quality Assurance Specialist - EFOR (Madrid)
🏢 Talent
📍 Madrid