Greater Hamburg Area
- more than 10 years of experience in quality management, thereof more than 5 years in the field of medical devices and pharmaceutical industry - very good knowledge of ISO 13485, ISO 14971, EU and FDA regulations, GMP, MDR - experience in conducting supplier audits - Expert in validation and qualification of software and computer systems - Deep knowledge in device qualification, FAT, SAT, DQ, IQ, OQ - Risk management process, risk analysis, FMEA, - Leading function with up to 20 employees - German native language, fluent English and Spanish skills
Sr CSV / Automation Expert Commissioning/Qualification and validation of process control systems Planning, monitoring and implementation of qualification and validation incl. VP, RA, URS, DQ, IQ, OQ, PQ, Coordination with stakeholders (Business, IT, and QA)
Quality Assurance and Regulatory Affairs for Pharma, Medical Device and Biotech Equipment Qualification, QC / QA, Automation, Computer System Validation, Coaching & Training http://www.arete-consult.eu/index.php/en/
CSV Expert Create validation documents (VP, RA, URS, TP, TC, TM and VR)
Sr CSV Expert, Create validation documents (VP, RA, URS, TP, TC, and VR) Management of the SOP harmonization project: analysis of the existing SOP landscape, creation of an overview of the deliverables, expansion or adaptation of the existing SOPs, writing and finalizing the new SOPs, coordination with stakeholders (business, IT, and QA)
Remediation Project Data Integrity Audit Trail Update of audit trail review process. Training and guidance of the QA AT team. Support Win 10/Win 11 GxP rollout.