Quality Compliance Coordinator

‎3803 Viatris Egypt S.A.E
At VIATRIS, we see healthcare not as it is but as it should be. We act
courageously and are uniquely positioned to be a source of stability in a
world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access - Providing high quality trusted medicines regardless of geography or
circumstance;
Leadership - Advancing sustainable operations and innovative solutions to
improve patient health; and
Partnership - Leveraging our collective expertise to connect people to
products and services.

Every day, we rise to the challenge to make a difference and here's how the
Quality Compliance Coordinator role will make an impact:
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
At Viatris, we offer competitive salaries, benefits and an inclusive
environment where you can use your experiences, perspectives and skills to
help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.