Quality Assurance Specialist
hace 2 semanas
[a few high level lines to describe the mission of the role]
What you will do
Part of the DCU working in Global and multicultural Team that assures customer complaints are captured, assessed for reportability, processed and resolved in a timely matter as per applicable internal and regulatory requirements. To provide input, carry on Global Projects and improvements related to complaint handling processes. To be a key contact person for stakeholders and ensures that Global complaint process inspections and Audits (internal and external) are prepared and covered on local market. - Be a key contact person to local Customer Service, Affiliates, LPoC to ensure correct information intake and day to day work. Be responsible for local Audits / FDA Inspection as planned. Lead assigned Global/Local complaint processes and projects. - Perform follow ups with investigators/LPoC/others to ensure complaints are processed in a timely manner. Continuously review complaint files to ensure documentation is performed according to requirements (internal/external) and in line with GDP needs. - Perform initial screening of new complaints to determine potential reportability, investigator and appropriate investigation location.-
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