Quality Consultant – Process Validation & GMP

About the role

We are seeking a Quality Consultant specialized in process validation and GMP to join our German team. The consultant will work on pharmaceutical and biotechnology projects, ensuring compliance with regulatory standards and supporting our clients’ quality initiatives.

Key responsibilities

• Review, approve and maintain validation and process documentation.
• Support GMP compliance initiatives and drive quality improvement programs.
• Participate in deviation investigations, CAPA management and change control activities.
• Collaborate with Quality, Manufacturing, MSAT and Validation teams to ensure alignment.
• Assist with inspection readiness, audits and regulatory inspections.
• Contribute to continuous improvement and quality excellence initiatives.

Required profile

• Degree in Pharmacy, Biotechnology, Chemistry, Life Sciences, Engineering or related field.
• Professional experience in Quality Assurance, Validation, CQV or Quality Systems within the pharmaceutical industry.
• Strong knowledge of GMP requirements and pharmaceutical quality systems.
• Experience with validation documentation, deviations, CAPAs and change controls.
• English proficiency required; German language is an advantage.

Required skills

• Process validation
• GMP compliance
• Validation documentation
• Deviation management
• CAPA handling
• Change control
• Sterile manufacturing
• Biologics and injectable product knowledge

What we offer

• Key role in a fast‑growing European Life Sciences consultancy.
• Opportunity to shape the growth of the German and DACH operations.
• International work environment with colleagues across Europe.
• Extensive onboarding and continuous technical training.
• High level of autonomy and ownership.