Product Quality Expert

Takeda

Neuchatel, Switzerland
**
Product quality reviews (pqr)
Regulatory license sections
Gmp inspections
** Takeda is seeking a Product Quality Expert in Neuchatel, Switzerland, responsible for ensuring regulatory compliance and quality standards for a biological product. The role involves preparing documentation, managing quality reviews, and collaborating with regulatory affairs while offering a comprehensive benefits package that emphasizes employee well-being and career development. **

Job Summary

  • As a Quality Product Expert, you will be responsible for one biological product manufactured on site and act as an expert for all the topics related to regulatory compliance for this product.
  • Prepare Product Quality Reviews (PQR) for products manufactured at the Neuchâtel facility, annually and according to health authority requirements.
  • We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance.

Matching Summary

Match Score: 75

** Takeda is seeking a Product Quality Expert in Neuchatel, Switzerland, responsible for ensuring regulatory compliance and quality standards for a biological product. The role involves preparing documentation, managing quality reviews, and collaborating with regulatory affairs while offering a comprehensive benefits package that emphasizes employee well-being and career development. **

Skills & Requirements

Must-have

  • Product Quality Reviews (PQR)
  • regulatory license sections
  • GMP inspections
  • change controls
  • audit observations
  • regulatory agency questions

Nice-to-have

  • continuous training
  • work-life balance
  • inclusive, collaborative workplace
  • patient-focused company

Key Requirements

  • 3-5 years of experience
  • biotechnology and/or pharmaceutical industry
  • writing and/or reviewing eCTD licenses
  • regulatory affairs framework (CMC)
  • FDA, EMA, ICH regulations
  • Fluent in English & French

Work Rights

Not specified

Tailored Resume

Cover Letter