Senior GxP / CSV Consultant

Project overview

For a leading pharmaceutical/biopharmaceutical company, we are looking for an experienced GxP expert to support a transformation and compliance project.

The focus is on consulting and implementing regulatory requirements in the area of computerized systems (CSV) as well as ensuring compliance with GAMP5 and GxP guidelines.

Responsibilities

• Consulting on GxP requirements and regulatory standards
• Support with CSV activities and validation strategies
• Creation and review of validation documentation
• Design and optimization of change control processes
• Evaluation of make-or-buy scenarios from a compliance perspective
• Collaboration with QA, IT, and business departments

Requirements

• Several years of experience in the pharmaceutical or biopharmaceutical environment
• Sound knowledge of GxP, GMP, CSV, and GAMP5
• Experience with computerized systems in regulated environments
• Experience in quality and compliance management
• Very good English skills, German an advantage

Nice to have

• Experience with LIMS, MES, or SAP
• Audit and inspection experience
• Background in Quality Assurance or Validation Management

Project details

26.10.2026

until 15.01.2027

Utilization: 25-50%

100% Remote (Germany preferred)

Industry: Pharma / Biopharma

• Start: ab sofort
• Remote: hybrid
• Location: Heidelberg, Deutschland, DE
• Languages: German