Quality Assurance Investigations Coordinator At Viatris Egypt
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 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