Job Information
About the Position
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.
Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We also develop clinical software applications and laboratory instrumentation systems enhancing patient care.
We operate directly in 30 countries, and in more than 100 territories through distributors. Our headquarters and technology centers are located in Europe and the United States, and our workforce is more than 7,000 strong.
In Werfen, our purpose is to contribute to the advancement of patient care around the world through innovative specialized diagnostics solutions.
Job Summary
The mission of this position is to guarantee that the Standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where Werfen OEM sells the products. Assure that all products manufactured at Werfen OEM are designed, manufactured and released according to established procedures. In addition this role works with specific manufacturing teams to drive continuous improvement of Quality within manufacturing – seeking defect rate reduction, increased manufacturing efficiency, reduced costs and enhanced customer satisfaction.
Key Accountabilities
- Review and approval of manufacturing and general procedures
- Development of Quality Improvement plan for manufacturing area of responsibility
- Measurement and reporting of Quality KPIs and metrics for manufacturing area of responsibility
- Change Management: evaluate the impact of the proposed changes and management of change control.
- Validation: Be able to establish a strategy to validate changes. Review and approve validation strategies and the corresponding documentation (protocol and report)
- Risk Assessment: perform, review and approve the risk assessment performed at werfen OEM to evaluate the impact of changes and non-conformances in the final product
- Participate in Internal and External Audits
- Perform Quality Training to all personnel at Werfen OEM.
- Management of Non-Conformities and CAPA
- Review of product Batch Record as needed.
Networking/Key relationships
The main interactions are with:
- Operations area.
- Quality Control.
Minimum Knowledge & Experience required for the position:
- Education:
- Required: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology or other Sciences.
- Degree may be substituted by relevant skills and work experience
- Valuable: Any additional degree higher than the required
- Experience:
- Additional Skills/Knowledge:
- Software: Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAP
- Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)
- Standards: Knowledge of Quality standards
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
- Management of decisions under pressure.
- Methodical and well-organized person.
- Teamwork
- Time management skills
- Ability to express information clearly and concisely to the staff, ensuring their understanding.
- Ability to apply a systematic approach and constant control, follow-up and verification of the results.
- Ability to collaborate, participate and coordinate actively with working groups
- Reflects values of Werfen in the quality of work and working relationship