Job Description

Manage commissioning and qualification of BioPharma equipments. Lead and assist with Factory acceptance test and Site acceptance test, IQ/OQ including documentation review and reporting, Manage the completion of FAT and SAT and post tasks, Handling KPI, Root cause analysis pertaining to qualification. High matured handling with customers. Willing to travel both domestic and international- 70% travel profileThe Customer Quality Professional will be responsible for interpreting, building upon, and complying with company service standards. The holder of this position will carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions.Main Responsibilities & Tasks:Inspect or verify services are compliant with applicable requirementsPlan, organize and conduct audits/assessments of supplier's systems, processes and productsWork with services to close out any audit findingsDocument and report audit/assessment resultsFacilitate quality issues in conjunction with key stakeholders, resolving day to day problemsPerform effective containment and problem resolution for all non-conformancesReport and assess status of service performanceProvide education and coaching on quality systems, regulatory compliance issues and company initiativesProvide support for product developmentQualification & Skills:Bachelor degree in a relevant science, engineering or related subjectMinimum 5-8 years\' experience in a quality and assurance development ideally within the biomedical or pharmaceutical industry with the ETO project background.Professional Certification In depth knowledge of Quality auditing, and regulatory standardsGood Technical Engineering knowledge, including ability to understand engineering drawing and standardsAbility to develop realistic work plans, set personal goals that align with company goalsWell-organized and methodical, with a superb attention to detailAbility to prioritize and manage daily assignmentsExcellent written and verbal communications skills to represent the company professionallyEstablish and maintain positive working relationships with all in and external interfacesFluent in EnglishAbout SartoriusSartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.Join our global team and become part of the solution. We are looking forward to receiving your application.

Sartorius