QA Validation Expert

As a QA Expert, you will report to the QA Manager and be responsible for ensuring compliance, validation, and data integrity during the implementation of the CHROMELEON system. You will represent Quality in both routine GMP activities and project-based Computer System Validation (CSV) efforts.

Industry: Biotech

Skills: QA Validation

Start of project: 19.05.2025

Duration of the project : 21.11.2025 

Key Responsibilities

Routine GMP Activities

• Act as the Quality partner in managing change controls related to the CHROMELEON implementation.
• Review and approve operational documentation supporting the new computerized system.

Project Responsibilities

• Serve as the QA representative in the CHROMELEON implementation project.
• Support all CSV-related validation activities, including:
  • Review of project documentation: URS, RIAS, IQ, OQ, PQ, risk assessments.
  • Ensure compliance with GMP, data integrity, and regulatory standards.
• Evaluate and approve validation strategies and documentation.
• Lead or review deviations and CAPAs in systems like TrackWise.
• Provide proactive QA feedback and communication across departments.
• Review and approve updates to controlled documentation.
• Report significant findings and risks to functional and senior leadership.

Essential Skills & Competencies

• Strong knowledge of FDA, EMA, ICH, pharmacopoeial regulations, and ISO standards.
• Expertise in QC laboratory equipment, especially HPLC and lab-based computerized systems.
• Deep understanding of CSV and validation of QC systems.
• Background in QC testing under GMP for biopharmaceutical products.
• High digital proficiency and affinity for automated systems.
• Self-driven, well-organized, and precise.
• Strong problem-solving skills with the ability to navigate complex challenges pragmatically.
• Able to manage priorities effectively in a fast-paced, regulated environment.
• Excellent written and verbal communication; adaptable to diverse audiences.
• Fluent in French; proficiency in English is a strong asset