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1201 F. Hoffmann-La Roche AG
19d ago

GMP Compliance Specialist(m/w/x)

Basel
Full-timeOn-siteExperienced

Description

In this role, you will be the go-to expert for GMP compliance, managing processes and supporting quality systems. Your day-to-day responsibilities will involve coordinating audits, optimizing compliance procedures, and fostering collaboration across teams and stakeholders.

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Requirements

  • Bachelor's degree or higher in Chemistry, Pharmaceutical Sciences, or equivalent
  • Experience in synthetic and/or large molecule manufacturing and quality control
  • Flexibility and teamwork skills
  • Curiosity about team priorities and workload
  • Empowerment to make decisions and ownership of work
  • Seeking feedback for continuous improvement
  • Excellent language skills, fluent in German and good communication in English

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

Tasks

  • Manage local GMP compliance processes
  • Coordinate quality risk management activities
  • Facilitate handling of deviations and CAPA
  • Support changes in GMP compliance
  • Act as an expert for quality systems
  • Provide first-level support for business processes
  • Train subject matter experts on quality systems
  • Manage access to GMP relevant areas
  • Oversee account management for GMP systems
  • Handle inspection management for internal audits
  • Prepare for health authority inspections
  • Drive optimization of GMP-related processes
  • Standardize the existing document landscape
  • Collaborate with team members in a role-based environment
  • Build relationships with customers and partners

Languages

GermanNative

EnglishBusiness Fluent

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