Investigation & Client Quality Specialist
Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
This is an outstanding chance to contribute to our world-class healthcare team and drive outstanding quality standards!
Job ResponsibilitiesManage deviations and investigations, including complaints and non-conformities in raw materials and GMP materials, ensuring timely completion.Coordinate the CAPA system derived from quality investigations.Prepare periodic quality trend reports for Management and Corporate dissemination.Support and actively participate in Operational Excellence initiatives and projects.Collaborate with various company functions to define causes and implement corrective action plans within specified timelines.Verify the efficiency of corrective actions over time.Coordinate and participate in technical and managerial meetings with clients.Participate in client visits, quality inspections, and internal regulatory inspections.Generate reports related to quality events.Achieve quality objectives in areas such as RFT, Deviation Rate, Past due, and Ontime closure.Contribute to Business/customer happiness objectives.Review and draft Quality System SOPs in collaboration with Compliance colleagues.Deliver timely client support via TLC and email.Draft FMEAs and manage controlled company documentation.Train personnel involved in quality PDS/DPS activities.Draft QATs, negotiate with Clients, site QPs, and legal, following the responsible person’s scheduling.Act as SME and QO reference for assigned projects, ensuring successful project completion and GMP batch disposition.Support Readiness and BU processes.RequirementsProven experience in quality management within a healthcare setting.Strong ability to manage investigations and corrective actions.Excellent communication and collaboration skills.Ability to successfully implement quality initiatives and meet rigorous standards.Ambitious and determined to support world-class healthcare solutions.Join us and make a difference in the healthcare industry. Apply today and become a part of an ambitious team dedicated to achieving flawless quality in everything we do!
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