Quality Assurance Officer

Há 6 dias

Lisboa, Portugal Viatris Tempo inteiro

1422 Mylan, Lda.

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 Regulatory Affairs Officer role will make an impact:
Key responsibilities for this role include:

- Conduct the quality assurance activities for Viatris products, in what regards compliance with the Marketing Authorization and with the Good Distribution Practices;
- Preparation, review and maintenance of Quality Standard Operating Procedures (SOPs);
- Quality oversight of batches released for distribution and ensure compliance with the Falsified Medicines Directive;
- Review of batch documentation;
- Review of data generated by temperature monitoring equipment;
- Management of Trackwise records;
- Management of Customer and Supplier Complaints;
- Processing of deviations and CAPA;
- Management of Quality Incidents;
- Management of Change Controls;
- Quality Risk assessments;
- Review of Product Quality Reviews (PQRs);
- Preparation and maintenance of Technical Agreements;
- Qualification of Customers and Suppliers;
- Management of shortages and Contingency plans.

The minimum qualifications for this role are:

- Degree in Pharmaceuticals Sciences
- Proficient English
- Minimum 3 year experience in Quality Assurance and Good Distribution Practices
- Ability to work under pressure and to strict deadlines
- Team-working

Preferences:

- Experience in Trackwise System;
- Experience in SAP System.
- Experience in review of batch documentation.

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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