Quality Assurance Investigations Coordinator At Viatris Egypt
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 GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory 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.
Coordinating and Performing investigations together with responsible person.
Key responsibilities for this role include:
Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory standards.
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 deviations.
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.
Development of various risk assessments.
Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA+ principles all over operations.
Responsibility for compliance with Viatris Quality Standards.
The minimum qualifications for this role are:
Bachelor’s degree in pharmaceutical sciences.
0-2 years of experience in Quality in Pharmaceutical field.
Experience in manufacturing processes is a plus.
Good command of English both written and spoken.
Strong interpersonal and influential skills
Excellent in communication and project management
Decision-making based on a risk science-based approach
High analytical skills.
Professional in reports writing.
Preferred Qualifications:
Six Sigma (Yellow/Green belt).
Expert in all type of Events (Incidents/Investigations, LIRs, Complaints and EHS).
Experience with relevant Track Wise modules.
Project Manager, team leader/project leader and coach.
Experience in PQS/WHO/PQS requirements.
QRM practitioner.
Trained on investigator/SQA curricula.