Analytical Process Transfer and Reliability Specialist

Responsibilities

• Perform technical analysis of analytical data and evaluate gaps against regulations and laboratory procedures
• Organize feasibility, development, validation, and transfer of analytical methods both internally and externally
• Draft protocols and reports and supervise analytical testing activities
• Plan and organize analytical studies for stability (preliminary, ICH, etc.) in coordination with new products
• Support the submission of variations by managing process validation and comparative dissolution studies
• Ensure site documentation is updated in compliance with regulatory guidelines (EMA, ICH, pharmacopoeias)
• Conduct periodic reviews of analytical processes and propose remediation plans when necessary
• Manage troubleshooting activities, including feasibility studies and technical reporting

Requirements

• Bac +5 degree (Engineer, Master, or Pharmacist) in Quality Control or a related field
• Experience in a Quality Control laboratory, specifically in development
• Technical mastery of analytical methods, including development, validation, and transfer
• Knowledge of technical writing for Marketing Authorization (AMM) dossiers, specifically Module 3
• Fluency in both French and English

Preferred Qualifications

• Previous experience working within the pharmaceutical industry

About the Company

Viatris is a global healthcare company dedicated to providing access to high-quality medicines for approximately 1 billion patients annually. By combining the strengths of generics and branded products, we aim to empower people worldwide to live healthier at every stage of life.