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 OEM sells the products. Assure that all products manufactured at 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 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 OEM
Management of Non-Conformities and CAPA
Review of product Batch Record as needed
Networking/Key Relationships The main interactions are with Operations area and Quality Control.
Minimum Knowledge & Experience Required for the Position Education/Experience:
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
Required Experience: 3 years in a similar position
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
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
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