Quality Compliance Section Head

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 heres how the “Quality Compliance Section Head” role will make an impact: Position Summary:

• Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with GMP standards.
• Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site.
• Responsible for Ensuring DI, Change Management, SSIs

Key responsibilities for this role include:

• Develop Data Integrity Plan and deployment of the plan per committed timelines.
• Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.
• Should perform unannounced data integrity surveillance audits.
• 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 and escorting of quality-related audits conducted by Corporate and regulatory agencies.
• Participate in draft responses to audit observations.
• Responsible for managing assigned Viatris global policies gap assessments.
• Responsible for insurance of compliance with Global Quality Standards
• Participate in Site Self Audit program as a lead auditor and managing Site Self-Appraisals Program
• Oversee regulatory commitments and Health Authority queries.
• Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.
• Active implementation of Notification to Management procedures.
• 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, Site-Self Appraisals
• Approval of Interims related to Change Management.
• Share in escorting MOH visits related for approval of Major Changes.
• Managing regulatory artwork changes requested by the site.
• Delegate Senior Quality Associate (Compliance) in case of absence.
• Delegate for Site Quality Compliance & Technical Regulatory Manager in his absence (if needed).

The minimum qualifications for this role are:

• Bachelors degree in science / pharmaceutical sciences.
• Minimum 5-8 years experience in Quality Functions.

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 and Viatris quality Standards.

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.

Information :

• Company : Viatris
• Position : Quality Compliance Section Head
• Location : Cairo
• Country : EG