CQV Expert

What We Offer:

• Competitive compensation based on experience and project scope.
• Exposure to international pharmaceutical operations and regulatory environments.
• Opportunity to lead high-impact injectable validation programs.
• Flexible work arrangements and travel support.
• Collaborative and technically driven work culture.

• Bachelors or masters degree in Pharmacy, Biotechnology, Engineering, or related scientific discipline.
• Minimum 3 years of experience in pharmaceutical validation.
• Deep understanding of cleanroom classification, HVAC qualification, and contamination control.
• Proven experience in environmental monitoring program design and execution.
• Strong knowledge of GMP, Annex 1, ICH Q8-Q10, and validation lifecycle principles.
• Hands-on experience with CAPA management and Change Control systems.
• Demonstrated ability to lead cross-functional teams and mentor junior staff.
• Excellent communication and documentation skills.
• Fluent in Spanish and English (advanced or native level required).
• Willingness to travel.

Preferred Experience:

• Experience with injectables and solid forms.
• Strong understanding of aseptic processing, terminal sterilization, and cleanroom operations.
• Hands-on experience with CAPA systems, Change Control management, and quality documentation workflows.

Position Title: CQV Expert

Location: Madrid

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 global 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, and Change Controls related to qualification and validation activities.
• Provide technical training and mentoring to client teams on validation and environmental control best practices.
• Prepare detailed reports and executive summaries for internal and external stakeholders.
• Travel to client sites for project execution, troubleshooting, and validation support.

Type of Contract: Full-Time / On site