Commercial Quality
hace 6 días
**Commercial Quality & Regulatory Affairs-PV Coordinator | Paraguay, Uruguay & Bolivia**
**-**
**236207**
**Our company**
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
**The position**
As Commercial Quality (HP & AH) and AH Regulatory Affairs and PV Coordinator, responsibilities are focused on implementation and maintenance of Local Quality, Regulatory and PV requirements for Uruguay, Bolivia and Paraguay according to the Business Models for each Country.
**Tasks & responsibilities**
- The Commercial Quality (Animal Health & Human Pharma) and Animal Health Regulatory Affairs (RA) & PharmacoVigilance (PV) coordinates the Uruguay, Bolivia & Paraguay Cluster team:
- To maintain and align priorities with Regional RA &PV Team.
- Quality Management Review.
- Act as liason with distributors.
- Batch Disposition.
- Discrepancy Managment.
- Quality decisions related with potential for market actions and recalls.
- Repackaging.
- Local Quality Control (where required).
- Knowledge Management.
- Self inspections.
- Submissions for Marketing Authorizations AH Products & HA Requests.
- Artwork and Promotional Materials Approval.
- Pharmacovigilance reporting and training.
**Requirements**:
- Soft Skills: Teamwork, leadership and communication skills, agility, accountability and intrapreneurship in order to act transversely through the organization.
- Understanding of Business strategy.
- Job Expertise:
- GxP knowledge.
- Experience in Distribution, production and QC desirable.
- Knowledge in Local Regulations for Countries under scope.
- Min. 3 years of Experience in Pharmaceutical industry.
- Academic profile:
- University degree in Pharmaceutical Chemistry (Desirable).
- Level of English: Advanced.
**Why Boehringer Ingelheim?**
With us, you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.
**Puesto**
- Calidad
**Ubicación principal**
- Americas-UY-Montevideo
**Organización**
- UY-Boehringer Ingelheim Animal Health Uruguay S.A.
**Horario**
- Tiempo completo
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