Quality Compliance Coordinator

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:

• Position summary:
• Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Global Standards.
• Ensure that appropriate systems are in place to meet or exceed the requirements of the company, and regulatory authorities for the quality of the products manufactured on site.
• Responsible for Ensuring DI at the site, Change Management and Site Self-Appraisals Program.

• Job Description:
• Quality Oversight of Local External Suppliers sourcing materials to Viatris- Cairo Site.
• Conduct a pre-audit and periodic Quality visits to assess the supplier’s site level of Compliance to GMP Quality and Data Integrity requirements.
• Review pre-audit questionnaires completed by the supplier.
• Conduct awareness training sessions for Suppliers on various GMP related topics such as Data Integrity, Good Documentation Practice and Change Control
• Support in drafting Quality Agreements and submission for review and approval
• Support in tracking and approval of Supplier Qualification reports
• 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
• 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
• Delegate for Senior Quality Associate (Compliance) in his absence (if needed).

The minimum qualifications for this role are:

• Bachelor’s degree in science / pharmaceutical sciences.
• Minimum 2 years of experience in quality assurance or compliance department.
• Essential Personal Qualifications:
  • 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.
• Preferred Qualifications:
  • Six Sigma (Green/ Black belt) is a plus.
  • Knowledgeable of GMP & regulatory quality Standards

At Viatris, we offercompetitivesalaries, benefitsandan 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.