Senior Quality Control Analyst (Stability & Method Validation)

About the role

Viatris Egypt is looking for a Senior Quality Control Analyst responsible for the QC laboratory functions of stability and method validation, and the supporting documentation, so that products can be disposed of in a timely manner. The role also covers data integrity, regulatory compliance and acting as deputy to the QC Stability and Methodology Section Head.

Key responsibilities

• Ensure all results comply with data integrity requirements and raise notifications of critical quality events when required by company policy.
• Carry out RFT projects for M1, M2 and M3, and perform all method validation activities, including protocols and reports.
• Take part in stability out-of-specification and failure investigations, and support the outsourced manufacturing department by sending stability samples on time, evaluating results and archiving them.
• Create, review and maintain stability schedules, protocols, reports and trends, and handle global changes affecting stability and methodology.
• Support QA with CCRs and QARs related to stability and methodology, implement the data integrity program and follow ALCOA principles.
• Comply with Viatris Quality Standards and act as deputy to the Section Head and the specialist when they are absent.

Required profile

• Bachelor's degree in pharmacy or a scientific background.
• Previous experience in a laboratory environment.
• Good understanding of the pharmaceutical regulatory process and sound knowledge of general laboratory safety.
• Excellent command of English, strong documentation and technical writing skills, and good teamwork and communication skills.
• Active, organized, detail-oriented and able to work independently and meet deadlines.

Required skills

• MS Office: Word, Excel and PowerPoint.
• Knowledge of data integrity and ALCOA principles.