QA Site Representative – French Required
We are seeking an experienced QA Representative Manager to join our client's Pharma Operations team. The company is a leading biopharmaceutical firm with a globally recognized product portfolio.
In this role, you will represent Quality in cross-functional project teams, ensuring all quality aspects are managed efficiently and in compliance with global policies, SOPs, GMP standards, and regulatory requirements.
You will serve as the Quality Validation representative for site and global project implementation, providing quality and compliance expertise for validation activities, including equipment, utilities, room qualification, and Computerized System Validation (CSV).
Key Responsibilities:
* 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.
Requirements:
* 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.
About the Company:
* 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.