Quality Compliance Coordinator At Viatris Egypt
Key responsibilities for this role include:
Follow-up Data Integrity Plan and deployment of the plan per committed timelines and report any delays to Quality Compliance Section Head
Should perform Site Self-Appraisal audits as Lead Auditor
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.
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.
Responsible for tracking and reviewing assigned global Viatris Policies Gap Assessments.
Responsible for insurance of compliance with GMP and Viatris Global Quality Standards
Active implementation of Notification to Management procedures.
Approval of child actions and ensure that child actions are correctly created.
Perform Quality Impact Assessment for Site changes and support site project managers to process their changes.
Monthly tracking and review of Internal Audit, BOH Actions, QAS Actions and Change Management metric
Support in drafting Quality Agreements and submission for review and approval
Support in tracking and approval of Supplier Qualification reports
Ensure compliance of Change Management System with global standards
Conduct and review impact assessments for all changes.
Approval of child actions and ensure that child actions are correctly created.
Approval of child actions interims
The minimum qualifications for this role are:
Personal and Technical Skills
Good command of English both written and spoken.
Knowledgeable with interpersonal learning.
Good Communication skills.
High Precision and Accuracy.
Decision making skills.
High analytical skills.
Education and Experience:
Bachelor’s degree in Pharmaceutical Sciences
Minimum 1-3 years’ experience in pharmaceutical operations in Quality