Quality Assurance Coordinator (Release & Doc.) at Viatris Egypt
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Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Associate Documentation and Release
Key responsibilities for this role include:
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.
Approval of Updated Bill of Material “BOM” and Activation.
Approve the product in SAP.
Document Control:
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.
Responsible for GMP documents issuance and reconciliation
Documentation system D2 coordinator: support the whole site in D2 issues.
Experience and knowledge:
Bachelor’s degree in Pharmacy or Scientific background
High physical and technical skills
Good command of English language
High observation skills
The minimum qualifications for this role:
Bachelor’s degree in Pharmacy or Science.
2-4 years’ experience in a related area.
Demonstrated ability to work independently.
Excellent documentation and technical writing skills.
Able to work in a team, interact with various priorities and meet deadlines.
Active, organized and planner with high attention to details.
High observation skills.
Hard worker & self-motivated.