QA Vacancy At Viatris Egypt
Quality Assurance Coordinator (Release & Doc.) At Viatris Egypt
Position summary:
Revision of batch records before product release to ensure compliance with site procedures.
Participate in document control process within VIATRIS Cairo site.
Participate in preparation, execution and reporting of site validation and calibration activities.
Job Specific technical/Functional/Professional Competencies:
Batch records review and Release activities:
Review of batch documentation and assure strict adherence to written procedures.
Ensure applying of GMP rules during review of batch documentation.
Participate in Creation Printing and Update of master batch records.
Batch Record Review and Archiving.
Revision of the product results of analysis on QIS.
Participate in internal and external audit programs as Lead Auditor.
Document Control:
SOPs and FORM updates.
Master batch record management.
TW actions tracking.
Routing and Obsoleting SOPs and Documents on D2.
Review and approval of Master Batch records, Cleaning SOPs and any other GMP documents as required.
Participate in deviations investigations.
Documentation system D2 coordinator: support the whole site in D2 issues.
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 science / pharmaceutical sciences.
Essential Personal Qualifications:
Good command of English both written and spoken.
Knowledgeable with interpersonal learning.
Communication, teaching and coaching skills.
Logic way of thinking
High analytical skills