Senior Requalification Lead - GMP Facilities (Remote)

EFOR; Espanha; Teletrabalho; EUR 90 000 - 150 000; Tempo integral

Resumo da oferta

EFOR is seeking a Requalification Lead to drive the strategy, execution, and oversight of equipment and facility requalification activities. You will maintain the validated state of GMP facilities in line with FDA/EMA/PIC/S, define review cycles, and lead risk-based strategies across a broad portfolio of assets.

Responsibilities include developing IQ/OQ/PQ programs, qualifying process support equipment and clean utilities, and ensuring inspection readiness while maintaining data integrity across

Qualificações

• Bachelor's degree in a relevant field (Engineering/Life Sciences)
• Minimum 10 years of GMP equipment qualification experience
• Deep understanding of FDA, EMA, and PIC/S requirements
• Experience with CTU qualification and continued process verification
• Proven leadership and cross-functional collaboration skills

Responsabilidades

• Develop, implement, and oversee the equipment requalification lifecycle (IQ/OQ/PQ) and continued process verification
• Establish qualification protocols and schedules for process support equipment and utilities
• Lead requalification efforts for clean utilities and environmental monitoring
• Ensure inspection readiness and data integrity across qualification documentation
• Perform risk assessments to prioritize systems and define requalification strategies
• Collaborate with QA, Engineering, and Validation to ensure regulatory compliance
• Support global site qualification with remote work and travel as needed
• Identify gaps and drive corrective actions for qualification issues

Conhecimentos

GMP knowledge

Equipment qualification

IQ/OQ/PQ

Risk assessment

Regulatory compliance

Leadership

Formação académica

Bachelor's degree in Engineering/Life Sciences

Descrição da oferta de emprego

EFOR is seeking a Requalification Lead to drive the strategy, execution, and oversight of equipment and facility requalification activities. You will maintain the validated state of GMP facilities in line with FDA/EMA/PIC/S, define review cycles, and lead risk-based strategies across a broad portfolio of assets.

Responsibilities include developing IQ/OQ/PQ programs, qualifying process support equipment and clean utilities, and ensuring inspection readiness while maintaining data integrity across