Senior Quality Assurance Associate (Comp.) At Viatris Egypt
Cairo, Egypt
Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Associate (Comp.) role will make an impact:
Key responsibilities for this role include:
Develop Data Integrity Plan and deployment of the plan per committed timelines and report any delays to Quality Compliance and Technical Regulatory Manager
Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.
Responsible for Computer System Validation (CSV) for site
Managing regulatory artwork changes requested by the site.
Should perform Site Self-Appraisals as Lead Auditor and ensure on-time attainment of monthly Site self-appraisals plan
Manage team and team priorities through daily tier
Member of Site Quality Review Team
Should participate in the investigation and corrective action for reported improper practice.
Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.
Provide feedback to management on periodic basis in relation to overall compliance on data integrity.
Shall give awareness training on reported observations, share industry insights.
Responsibility for implementation of Data integrity program in the relevant work area and ensure following up ALCOA principles all over operations.
Share in the preparation for quality-related audits conducted by Corporate and regulatory agencies and can be member of inspection team as escort, scribe, runner and/or backroom manager
Monthly tracking and review of Internal Audit, BOH Actions and Change Management metric and support to resolve any constraints and report any risks to management
Draft responses to audit observations.
Responsible for managing and reviewing assigned Viatris Policies Gap Assessments.
Responsible for insurance of compliance with Global Standards
Oversee regulatory commitments and Health Authority queries.
Active implementation of Notification to Management procedures.
Change Management process owner and responsible for handling change management system
Ensure compliance of Change Management System with global standards
Conduct and review impact assessments for all changes.
Approval of all site changes.
Approval of child actions and ensure that child actions are correctly created.
Supervising and coaching change management team for handling changes process.
Approval of Interims related to Change Management parent record.
Share in escorting MOH visits related for approval of Major Changes.
The minimum qualifications for this role are:
Personal and Technical Skills
Robust Knowledge of GMP Guidelines in Pharmaceutical Industry
Strong Advocate for Quality and GMP Compliance
Lead Auditor
Good command of English both written and spoken
Leads by example and follows through on commitments
Strong Project Management Skills
Good Communication and Problem-Solving Skills
High Precision and Accuracy
Decision making skills
Education and Experience:
Bachelor’s degree in Pharmaceutical Sciences
Minimum 7 years’ experience in pharmaceutical operations