Quality Assurance Investigations 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 Assurance Investigations Coordinator) role will make an impact:
Position summary:

- 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.
- Coordinating and Performing investigations together with responsible person.

Job Specific technical/Functional/Professional Competencies:

- Preparation of monthly quality metrics to follow-up the performance of deviations handling system.
- Responsible for performing the “Deviations Handling system related to manufacturing, complaints, and laboratory”.
- Responsible for approving and follow-up of the Corrective Actions/Preventive Actions generated from investigations, complaint, PMSI & others.
- Share in the preparation of quality-related audits conducted by Corporate and regulatory agencies.
- Share in the preparation of the issues that require Quality Council attention.
- Member of the Internal Audit Team.
- Accountable for QTS actions (CCR/Investigations/Interims, etc.).
- Development of various risk assessments.
- Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA and ALCOA+ principles all over operations.
- Responsibility for compliance with Viatris Quality Standards.
- Active implementation of Notification to Management procedures.
- Responsibility for compliance with Viatris Quality Standards.
- Accountable for authoring quality related documentation (SOPs, Controlled documents, Risk assessments, Standard testing procedures,etc.).
- Delegate for QA investigation Senior Associate in case of his absence.

Experience and Knowledge:

- Bachelor’s degree in pharmaceutical sciences.
- From 1-2 years of experience with a strong technical background in cGMP and Quality Operations in Pharmaceutical field.
- Experience in manufacturing processes is a plus.
- QRM Practitioner.
- HP Practitioner.

Essential Personal Qualifications
- Excellent in communication, teaching, and coaching skills.
- Decision-making based on a risk science-based approach.
- Good command of English both written and spoken.
- Knowledgeable with interpersonal learning.
- Logic way of thinking with high analytical skills.
- Good planning and organization skills.
- Strong interpersonal and influential skills.
- Professional in reports and technical writing.

Preferred Qualifications:

- Six Sigma (Yellow/Green belt).
- Expert in all types of Events (Incidents/Investigations, LIRs, Complaints and EHS).
- Experience with relevant TrackWise modules.
- Experience in PQS/WHO requirements.
- QRM practitioner.
- Experience in QA/ QC/Compliance

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.