Senior Quality Assurance Associate

3 days ago

مصر, Egypt Viatris Full time

3803 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 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.
- 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.

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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