PharmEng / Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated QA Validations Expert to join our team.
Position Title: QA Validations Expert (Weekends / On-Site, Madrid)
Location: Madrid
Type of Contract: Full-Time
Position Summary
The QA Validations Expert is responsible for leading validation activities across manufacturing, laboratory, and computerized systems. This role ensures compliance with GMP standards, regulatory requirements, and internal quality policies, contributing to the integrity and reliability of pharmaceutical operations.
Spanish and English Fluent are mandatory
Key Responsibilities
Review and approve validation protocols (IQ/OQ/PQ/PPQ) for equipment, facilities, utilities, cleaning, and processes as well as FAT and SAT.
Ensure compliance with FDA, EMA, ICH Q7/Q8/Q9/Q10,



and other applicable regulations.
Perform risk assessments and gap analyses to support validation strategies.
Collaborate with cross-functional teams (Engineering, Manufacturing, QC, IT) to coordinate validation activities.
Maintain validation master plans and ensure timely execution of validation lifecycle documentation.
Manage deviations and non-conformances related to validation and propose corrective and preventive actions.
Evaluate the impact of proposed process/product changes (Change Management).
Support internal and external audits, providing validation documentation and responses.
Train personnel on validation procedures and regulatory expectations.
Review and approve manufacturing procedures and technical changes.
Propose and implement improvements to enhance Quality System robustness and best practices.
Qualifications
Bachelors or masters degree in pharmacy, Chemistry, Biotechnology, Engineering, o

📌 Weekend On Site QA Validations Expert (Madrid)
🏢 Project Delivery Partners
📍 Madrid