Quality Assurance Coordinator
6 months ago
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 Release and Documentation 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.
Job Specific technical/Functional/Professional Competencies:
Batch records review and Release activities:
- Review of batch record documentation and assure strict adherence to written procedure and GDP (Data integrity).
- Revision of the Quality control and IPC product results of analysis and approval of COA on Quality information system.
- Participate in deviations investigations.
- Participate in CCR impact assessment.
- Release of Finished goods products.
Document Control:
- Documents management, responsible for Creation, updating and obsoletion of documents (SOPs, FORMs, etc. )
- Master batch records management, responsible for Creation and updating of MBR.
- Actions tracking and implementing.
- Review and approval of documents on D2 documentation system.
- Documentation system D2 coordinator: support the site in D2.
- Batch record and QA documents archiving and retrieval.
Other:
- Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA principles all over operations.
- Active implementation of Notification to Management procedures.
- Responsibility for compliance with Viatris Quality Standards.
- Delegate for Senior Quality Assurance Associate Documentation and Release in case of his absence (if needed).
Experience and Knowledge:
- Bachelor’s degree in pharmaceutical sciences.
- From 1-3 years of experience with a strong technical background in cGMP and Quality Operations in Pharmaceutical field.
- Experience in manufacturing processes is a plus.
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).
- Experience with relevant TrackWise modules.
- Experience in PQS/WHO requirements.
- Experience in QA/ QC/ Quality 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.
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