An exciting new opportunity has emerged to contribute as a Quality Assurance Qualification & Validation Engineer at our Biotech drug substance plant.
Key Responsibilities
* Provide QA expertise for Process Validation, Analytical Validation, Cleaning Validation, and Raw Material Qualification.
* Develop qualification/validation strategies, review, and approve protocols and reports, participate in risk analysis, identify gaps, and create remediation plans.
* Serve as Quality Subject Matter Expert on specific topics, participate in risk assessments, and handle deviations on these topics.
* Review and/or approve qualification/validation documents, risk assessments, SOPs, and make quality decisions according to company standards.
* Ensure GMP compliance during all phases of qualification/validation.
Requirements
* University degree with at least 5 years of experience in pharmaceutical quality environments.
* Proven experience in analytical methods validation and manufacturing process validation.
* Strong communication and team spirit.
* Good stress resistance.
* Fluent in French and English (oral & written).