Quality Validation Specialist – CAPEX Projects

QA site Representative – French required

• Our client is a leading biopharmaceutical company, renowned for its globally recognized product portfolio. To support a significant ongoing investment project, we are seeking an experienced QA Representative Manager to join their Pharma Operations team.
• In this role, you will represent Quality in cross-functional project teams, providing oversight for commissioning, equipment qualification, and Computerized System Validation (CSV). Your primary mission will be to ensure all quality aspects are managed efficiently and in compliance with global policies, SOPs, GMP standards, and regulatory requirements.
• As a senior professional in Quality Projects, you may also take on specialized tasks in cross-functional initiatives, contributing to the success of transformative projects.

This specific assignment shall be started ASAP and is planned for 6 months with high probability of prolongation till end of 2025!

Project CAPEX Support:

• Serve as the Quality Validation representative for site and global project implementation.
• Provide quality and compliance expertise for validation activities, including equipment, utilities, room qualification, and Computerized System Validation (CSV).
• Collaborate with project teams to resolve quality issues and plan QA activities.
• Review and approve design documents, risk assessments, validation protocols, reports, deviations, and change controls.

Quality Assurance Activities:

• Promote compliance with data integrity and computer system validation regulations.
• Support the lifecycle of the strategic Quality Operations plan.
• Develop and implement QA training programs for production lines and associated processes.
• Perform quality risk assessments and support deviations and change control evaluations.

Operational Excellence:

• Demonstrate flexibility and dedication to meet project deadlines.
• Ensure effective communication between project stakeholders and within QA teams.
• Actively promote EHS policies, ensuring safety practices are implemented and followed.

Qualifications:

• Proven experience in Quality Validation, specifically in pharmaceutical or biopharmaceutical environments.
• Expertise in CAPEX projects, equipment, utilities, and process validation.
• Familiarity with cGxPs, regulatory guidance, and industry standards.
• Strong organizational, analytical, and problem-solving skills.
• Team player with the ability to work independently and drive cross-functional collaboration.

Why Join?

• Be part of a globally recognized leader in biopharmaceutical innovation.
• Collaborate on impactful projects that shape the future of healthcare.
• Work in a dynamic and inclusive environment that values growth and excellence.