Senior Quality Specialist - Thermo Fisher Scientific - São Paulo

Principal functions:

• Provide support to quality assurance and quality control activities in order to accomplish with quality company’s policies, based on the good manufacturing, distribution, clinical and documentation practices, and also the client requirements
• Ensure the correct operational activities according to local SOPs
• Perform local SOPs updates based on the FCS Network SOPs, local regulations and local operational requirements.
• Manage GxP trainings distribution via LMS system or classroom
• Manage issuance, revision, obsolescence and archival of Quality documentation based on Good Documentation Practices
• Follow up on validation, qualification, maintenance and calibration of equipment and GxP areas
• Perform and follow up on self-inspection audits
• Support on suppliers assessments, audits, qualification and elaboration of Quality Technical Agreement
• Provide support in Quality Control activities such as physical inspection and batch release of receipts in quality system (GPM and CTWin), shippers and materials inspection and release, check and release of relabeled materials (GPM system and manual form) and check of shipments as client requirements.
• Support on client/regulatory audits
• Support on KPIs elaboration
• Quality follow up in Deviations, Complaints and CAPAs development
• Ensure the correct execution of operational processes
• Development of all activities with safety and efficiency manner

Minimum Requirements / Qualification

• Knowledge in GMP and local regulation requirements
• Knowledge in Microsoft Office package, such as Outlook, Excel, Word, Power Point and Internet
• Experience in quality assurance and logistic activities
• Knowledge and experience in pharmaceutical and biological clinical logistic and clinical secondary packaging operation

Education

• Graduation in Pharmacy
• English advanced level (writing and speaking)

CANDIDATE-SE