QA Vacancy At Viatris Egypt
Title: Quality Assurance Investigations Coordinator
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 skills
- Excellent in communication and project management
- Decision-making based on a risk science-based approach
- Good 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.