Revvity tadqiqotlar, diagnostika va klinik testlar uchun yechimlar ishlab chiqadigan sog‘liqni saqlash va hayot fanlari kompaniyasidir. Uning mahsulot va xizmatlari genomik tahlil, dori vositalarini kashf etish, aniqlik tibbiyoti, hujayra va gen terapiyasi, klinik diagnostika hamda laboratoriyalarni avtomatlashtirishni qo‘llab-quvvatlaydi. Revvity akademik muassasalar, farmatsevtika va biotexnologiya kompaniyalari, klinik laboratoriyalar hamda sog‘liqni saqlash tashkilotlari bilan hamkorlik qilib, jamoalarga ilmiy tadqiqotlarni rivojlantirish va diagnostik hamda terapevtik innovatsiyalarni bozorga olib chiqishda yordam beradi.
Regulatory Affairs Quality Specialist - Brazil Remote
Support Revvity’s Brazil and LATAM healthcare quality operations through regulatory affairs, ANVISA compliance, QMS management, audits, CAPAs, regulatory files, and technical vigilance documentation.
Tavsif
- Draft registration dossiers and risk revalidations for managerial review and approval
- Maintain the Brazil RMP and Smart Sheets in line with manager guidance
- Support ANVISA Good Distribution and Storage Practices management with Responsible Technicians and CoRTs at the 3PL site
- Open and track Non-Conformities
- Monitor CAPAs with relevant departments
- Manage LATAM QMS documentation
- Support distributor qualification and requalification audits
- Support service-provider qualification and requalification
- Provide LATAM field-action and technical-vigilance documentation with company RTs and CoRTs
- Organize regulatory files according to manager guidance
- Draft and maintain regulatory affairs and ANVISA GDP/GSP procedures within the LATAM QMS
- Follow established processes and seek managerial guidance when necessary
- Complete other occasional activities agreed with the manager
- Follow Revvity policies and applicable LATAM QMS procedures
- Complete other occasional activities agreed with the manager
Talablar
- The posting does not specify experience, education, certifications, language requirements, or other qualifications.