An exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Expert for our Biotech Drug Substance plant in Corsier-sur-Vevey.
Responsibilities Primarily provide QA expertise in Process Validation and Equipment Qualification (including sterilization), Cleaning Validation, Raw Material Qualification, and Computerized System Validation as needed.
Elaborate the qualification/validation strategies and review/approve related protocols and reports.
Participate in risk analyses, identify gaps, and propose remediation plans.
Act as a Quality Subject Matter Expert on specific topics and support risk assessments and handle deviations on these topics.
Review and/or approve qualification/validation documents, risk assessments, SOPs and take quality decisions according to company standards.
Oversee qualification/validation phases from Basic Design until 1st use of equipment/raw material.
Ensure GMP compliance throughout all qualification/validation phases.
Qualifications Degree in Life Sciences, Engineering, or a related field (e.g., Biochemistry, Biotechnology, or Pharmaceutical Science).
Proven experience (4-9 years) in quality assurance, with expertise in qualification and validation processes in a GMP-regulated environment.
Solid knowledge in Process Validation. Knowledge in Equipment Qualification, Raw Material Qualification and Cleaning Validation is a plus.
Strong understanding of GMP guidelines and regulatory compliance requirements.
Analytical mindset with experience in risk assessment, deviation handling, and remediation planning.
Excellent organizational skills with the ability to review and approve technical documents such as protocols, reports, SOPs, and risk assessments.
Effective communication and teamwork skills.
French & English written & spoken.
Benefits We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.
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