Quality Manager Prague, Praha

Quality Manager

7084 Viatris CZ s.r.o.
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 Quality Manager role will make an impact:
The primary role of Local Quality Manager is to support local affiliate activities within the scope of EU GMP/GDP guidelines and company SOPs and directives.
Key responsibilities for this role include:
- Ensure Quality System implementation at affiliate level in compliance with GDP and applicable quality regulations
- GDP Quality Responsible Person or back-up
- Manage Quality/Technical agreements
- Quality Complaints / Investigations
- Ensure any market actions and product recalls as applicable, including oversight of local relabeling operations
- To be local point of contact for Health authorities in Quality questions
- Manage internal audits and inspections by Competent Authority and following CAPA
- implementation and closure
- Ensure relevant SOPs are in place and up to date and ensure compliance with global company SOP and local legislation, training
- Provide support for batch release sites and regional quality teams
- Perform Quality oversight for distributed batches / batch disposition
- Ensure Quality of Artworks
- Ensure monthly KPI reports
- Manage Serialization issues and other FMD related topics
- Carrying out self-inspections
- GXP Oversight of Warehouse operations
- Change control management
- Management of control drugs in accordance with GDP and local regulation
- Being Health Authority contact for Quality related topics
The qualifications for this role are:
- University degree in pharmaceuticals - PharmDr. (or other life science field)
- Previous experience in similar position
- Proven excellent communication and organization skills
- Interest in personal growth
- Highly advanced level of English
- Strong PC skills
- Detail oriented, hardworking personality
- Leading skills
- Team player - in this position, the emphasis is on open and also proactive cooperation with other departments and colleagues
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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