GxP Validation and Compliance for SaaS Solutions in the Pharmaceutical Environment

Project overview

Scope of Services

• Consulting for business units and technical teams on GxP-compliant software development and system validation
• Development of validation and qualification concepts
• Ensuring compliance with regulatory requirements and GAMP 5 compliant procedures
• Conducting and supporting risk analyses in the validation environment
• Support with requirements management, traceability, and compliance evidence
• Creation, review, and maintenance of validation and qualification documentation
• Evaluation of Data Integrity, Change Control, and Configuration Management processes
• Preparation and support for audits, inspections, and coaching of relevant stakeholders

Requirements

Contact Person: Manager Recruiting Ms. Alessa Adrian

FERCHAU Contract GmbH

Cologne Branch CONTRACT

Am Coloneum 6

50829 Cologne

• Several years of experience in a pharmaceutical company and in software development or validation environments within the pharmaceutical industry
• Sound knowledge of GAMP 5, Computerized System Validation (CSV), Computer Software Assurance (CSA), and risk-based validation
• Practical experience in SaaS lifecycle management and handling cloud-based solutions
• Extensive routine with validation documentation such as Validation Plans, Risk Assessments, Traceability Matrices, Test Plans, and Validation Summary Reports
• Confident handling of regulatory requirements, especially EU GMP Annex 11, FDA 21 CFR Part 11, and Data Integrity
• Familiarity with audit, compliance, and inspection processes
• Fluent English skills, both written and spoken

Project details

• Start: 2026-11-23
• Remote: remote
• Location: Darmstadt, Deutschland, DE
• Languages: German