Quality assurance specialist Jobs in Overath

Your role

You are working in the Clinical Research & Development department which conducts firstinman clinical trials and Phase III proofofconcept studies for our new assets worldwide.

• You ensure GCP compliance for the clinical trials in collaboration with Quality Assurance to support our departments objectives in meeting and GCPcompliance by providing structure identifying and supporting the resolution of issues on trial and process level through
• With respect to our activities you closely collaborate with the Quality Assurance department and crossfunctional Clinical Research & Development teams to develop QA / QC measures
• In addition you also plan and conduct activities related to compliance and inspection readiness including quality checks of TMFs and processes. You review and improve processes for efficiency effectiveness and compliance with regulations guidelines and quality policies and support site / CRO assessments.
• You will also coordinate and support functional / clinical trial teams in audit / inspection activities to ensure a consistent approach / action across clinical trials and programs. To improve functional processes and foster a culture of continuous improvement you identify analyze track and resolve findings regulatory and process gaps / nonconformances.
• By developing and implementing a lessonslearned culture you help to improve the quality of processes and documentation (in compliance with regulations guidelines quality policies) and minimize associated trial risks.

Qualifications :

Remote Work : Employment Type :

Fulltime

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Vacancy : 1