Gcp Quality Assurance Partner (m/w/d) *befristet Auf 2 Jahre*

Roche Holding AG

Grenzach, Germany
Gcp gdp gmp gvp knowledge
Qms implementation experience
Audit and inspection management
The role involves ensuring compliance with GCP, GDP, GMP, and GVP standards at the Grenzach location through an efficient Quality Management System

Job Summary

  • The role involves ensuring compliance with GCP, GDP, GMP, and GVP standards at the Grenzach location through an efficient Quality Management System.
  • Candidates will serve as the central QA role for RPAG, providing end-to-end quality oversight and managing regulatory inspections and internal audits.
  • Roche offers a culture that encourages personal expression and genuine connections, allowing employees to thrive personally and professionally while contributing to curing diseases.

Matching Summary

The role involves ensuring compliance with GCP, GDP, GMP, and GVP standards at the Grenzach location through an efficient Quality Management System.

Skills & Requirements

Must-have

  • GCP GDP GMP GVP knowledge
  • QMS implementation experience
  • Audit and inspection management
  • Project management skills
  • Cross-functional coordination

Nice-to-have

  • Lean Six Sigma methodology
  • Risk-based decision making
  • Strategic horizon scanning
  • Business case development
  • Resilience in complex situations

Key Requirements

  • Degree in natural sciences (Pharmacy, Biotech, Chemistry)
  • Experience in pharmaceutical industry
  • German native level and English C2
  • Knowledge of EU-GMP/GDP and AMG regulations

Work Rights

Not specified

Tailored Resume

Cover Letter