QA & RA Specialist (100 % workload)

For our customer Selectchemie AG we are looking for a QA & RA Specialist (100 % workload)

Workplace : Sao Paulo, Brazil

About Selectchemie AG

Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive technical, scientific, regulatory and commercial support all along the value chain. Worldwide, our 120 experienced professionals with commercial and scientific background, based at the headquarters in Zurich, Switzerland and locations in 18 countries, provide customers, principals and suppliers with solutions tailored to their needs.

Join our Pharma LATAM team

We offer a broad product portfolio of APIs & excipients and are an established hub for customers sourcing high-quality bulk raw material as well as for renowned manufacturers who benefit from our broad customer base in various markets. We are continuously expanding our global network as well as our services. We are seeking a QA & RA Associate to support our Pharma LATAM sales team in achieving their regulatory and quality assurance objectives, with focus on Brazilian and Mexican markets. This role involves close collaboration with internal teams, suppliers, and customers to ensure compliance with ANVISA and other relevant regulations. The ideal candidate will have a strong regulatory mindset, attention to detail, and excellent communication skills.

Tasks

ANVISA Submissions & API / Excipients Registration

• Prepare, submit, and manage ANVISA dossiers from our partners and of our ownership for API and excipient registrations, renewals, variations, and amendments, in accordance with RDC 359 / 2022 and RDC 361 / 2022, which require registration of APIs used in distribution and manufacturing in Brazil.
• Ensure compliance with ANVISA regulatory guidelines, monitor updates to regulatory frameworks, and implement required modifications proactively.
• Be designated as an authorized user in order to act on behalf of the suppliers for CADIFA application.

Life Cycle Management (LCM)

Regulatory Intelligence & Compliance

Client & Stakeholder Support

Documentation & Submission Management

Cross-Functional Collaboration

Process Enhancement & SOP Development

Training & Regulatory Advocacy

Requirements

Benefits

Please send us your CV along with your references and diplomas . Thank you in advance!

Wir suchen für unsere Kunden passende Kandidaten auf den Sozialen Medien.