Specialist Change Control & Validation (w/m/d)

Takeda UK

Oranienburg, Germany
Base: €79,800.00 - €109,780.00; bonus/equity: not ...
Gmp compliance knowledge eu/us/jp
Change control management implementation
Process and cleaning validation expertise
This role ensures the continuous improvement of process and product quality through rigorous change control management and validation oversight in alignment with cGMP guidelines

Job Summary

  • This role ensures the continuous improvement of process and product quality through rigorous change control management and validation oversight in alignment with cGMP guidelines.
  • The successful candidate will act as a central subject matter expert, coordinating changes across the site and approving critical validation documents and manufacturing instructions.
  • Takeda offers a comprehensive benefits package including 30 vacation days, subsidized healthcare, and opportunities for global career development at their Oranienburg production site.

Matching Summary

This role ensures the continuous improvement of process and product quality through rigorous change control management and validation oversight in alignment with cGMP guidelines.

Salary

Base: €79,800.00 - €109,780.00; Bonus/Equity: Not specified; Benefits: 30 vacation days; travel subsidy; health programs

Skills & Requirements

Must-have

  • GMP compliance knowledge EU/US/JP
  • Change control management implementation
  • Process and cleaning validation expertise
  • Electronic QMS proficiency TrackWise Veeva
  • SOP creation and review capabilities

Nice-to-have

  • Risk-based approach understanding CPP CQA
  • Audit representation experience
  • Strong organizational communication skills
  • Global regulatory affairs collaboration
  • Self-driven independent work style

Key Requirements

  • Degree in Pharmacy or Natural Sciences
  • Multi-year GMP environment experience
  • Fluent German and English language skills
  • Experience with SAP MES LIMS systems

Work Rights

Not specified

Tailored Resume

Cover Letter