Personal driver állások, munkák minőségbiztosítás kategóriában

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• QC of ICSR related activities to ensure compliance to Customer and regulatory agency requirements.
• Case intake activity for ICSRs related performance during the work.
• Ensure the Quality and TAT targets are defined and met.

Investigating and understanding the manufacturing processes and used raw materials, as well as troubleshooting issues and improving process efficiency....

Project Leadership & Strategy: Act as the technical lead for instrument hardware product care team, driving workpackage planning, implementation and resource allocation with line management...

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• Lead and manage the site's full CAPEX portfolio, ensuring prioritization, regulatory compliance and alignment with corporate strategy.
• Lead, coach and develop a team of Project Managers and Controllers, ensuring effective resource planning and high performance.

Provide essential guidance to laboratory colleagues on the planning, execution, and conclusion of analytical tests for in-process and intermediate analytics...

Acting as subject matter expert for global Quality applications (e.g. Veeva QualityDocs, Veeva QMS, LIMS and related systems), ensuring they remain compliant, user-centric, and fit for purpose....

Lead technical investigations for customer complaints and product CAPAs assigned to R&D, evaluate technical issues that occur during daily use of our systems in hospitals and act as key reference within the R&D team...