Job Description:

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 Senior CQV Consultant to join our team.

Position Title: CQV Expert

Location: Madrid

Type of Contract: Full-Time / On site

Position Summary:

The Senior Consultant in Qualifications & Validations is responsible for leading and executing validation activities across sterile injectable and oral pharmaceutical operations. This includes equipment, utilities, facilities, and process qualifications, with a strong focus on environmental monitoring and HVAC systems. The role supports multiple sites and projects, ensuring compliance with GMP and integral regulatory standards, while providing strategic guidance and technical leadership.

Key Responsibilities:
- Lead qualification protocols (URS, DQ, IQ, OQ, PQ) for manufacturing equipment, cleanrooms,



HVAC systems, autoclaves, and utilities.
- Develop and review validation master plans, risk assessments, and lifecycle documentation for injectable and oral processes.
- Oversee process validation, cleaning validation, and sterilization validation.
- Design and implement environmental monitoring programs, including viable and non-viable particle control, alert/action levels, and trending.
- Qualify HVAC systems including airflow visualization, pressure differentials, filter integrity testing, and temperature/humidity mapping.
- Ensure compliance with global regulatory requirements (FDA, EMA, WHO, PIC/S) and Annex 1 guidelines.
- Collaborate with cross-functional teams (Engineering, QA, QC, Manufacturing, Regulatory Affairs) to align validation strategies.
- Support audits and inspections by providing validation documentation and expert responses.
- Manage and resolve deviations, CAPAs, an

📌 CQV Expert (Madrid)
🏢 Project Delivery Partners
📍 Madrid