Senior Quality Assurance Associate (Investigations)

About the role

The Senior Quality Assurance Associate (Investigations) ensures that GMP standards and regulatory requirements are met for products manufactured at Viatris Egypt. You will lead investigations, manage deviations, and support continuous improvement of quality systems.

Key responsibilities

• Ensure GMP compliance for individual products and the site.
• Prepare and monitor monthly quality metrics for the deviations handling system.
• Act as process owner for the Deviations Handling system, performing quality reviews and impact assessments.
• Open investigations, conduct interviews, walk the process, and ensure timelines are met.
• Approve corrective and preventive actions generated from deviations.
• Prepare Global Quality Investigations Reports and conduct annual deviations trending.
• Support internal audits, risk assessments, and the implementation of the data‑integrity program (ALCOA/ALCOA+).
• Participate as a lead auditor in site internal audit campaigns.

Required profile

• Bachelor’s degree in a scientific field or equivalent pharmaceutical experience.
• Minimum 5 years of experience in investigations, CAPA, or manufacturing quality assurance within a cGMP environment.
• Strong knowledge of solid dosage form and semi‑solid manufacturing processes.
• Excellent written and spoken English with strong communication and project‑management skills.
• Ability to work with MS Word, Excel, and Access for data analysis and reporting.

Required skills

• TrackWise modules
• Deviations Handling system
• Risk assessments
• Data integrity program (ALCOA/ALCOA+)
• GMP standards
• Impact assessment
• Quality review
• Global Quality Investigations Reports
• QRM Practitioner
• Statistical analysis
• MS Word
• Excel
• Access
• HEP Practitioner
• Six Sigma (Yellow/Green Belt)

What we offer

• Competitive salary and benefits package.
• Inclusive work environment that values diverse perspectives.
• Opportunities to make a global impact on patient health.
• Equal Opportunity Employer.