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.
Job Specific technical/Functional/Professional Competencies:
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”.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 SQRT 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.Experience and Knowledge:
Bachelor’s degree in pharmaceutical sciences.0-3 years of experience in Quality in Pharmaceutical field (QA, QC, Validation)Experience in manufacturing processes is a plus.
Essential Personal Qualifications
Strong interpersonal and influential skillsExcellent in communication and project managementDecision-making based on a risk science-based approachGood command of English both written and spoken.Knowledgeable with interpersonal learning.Communication, teaching and coaching skills.Logic way of thinking.Management and decision-making skills.High analytical skills.Professional in reports writing.Preferred Qualifications:
Six Sigma (Yellow/Green belt).Expert in all type of Investigations (ER/QAR, LIRs, Complaints and EHS).Experience with relevant QTS modules.Project Manager, team leader/project leader and coach.Experience in PQS/WHO/PQS requirements.Experience with relevant QTS modules.QRM practitioner.Trained on QAR investigator/SQA curricula.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.