Quality Assurance Coordinator (Release & Doc.) 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.

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).
Ensure applying of GMP rules during review of batch documentation.
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.

Apply on Company Site 

تعديل المقال