Revvity
Revvity
Revvity स्वास्थ्य सेवा और जीवन विज्ञान क्षेत्र की एक कंपनी है, जो अनुसंधान, निदान और क्लिनिकल परीक्षणों के लिए समाधान विकसित करती है। इसके उत्पाद और सेवाएँ जीनोमिक विश्लेषण, दवा खोज, सटीक चिकित्सा, कोशिका और जीन थेरेपी, क्लिनिकल डायग्नोस्टिक्स तथा प्रयोगशाला स्वचालन में सहायता करती हैं। Revvity अकादमिक संस्थानों, फार्मास्यूटिकल और जैव-प्रौद्योगिकी कंपनियों, क्लिनिकल प्रयोगशालाओं तथा स्वास्थ्य सेवा संगठनों के ग्राहकों के साथ काम करती है, ताकि टीमें वैज्ञानिक अनुसंधान को आगे बढ़ा सकें और निदान तथा उपचार संबंधी नवाचारों को बाज़ार तक पहुँचा सकें।

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.

विवरण

  • 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

आवश्यकताएँ

  • The posting does not specify experience, education, certifications, language requirements, or other qualifications.

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