GxP Validation and Compliance for SaaS Solutions in the Pharmaceutical Industry

Project overview

We are looking for an experienced expert in GxP validation and compliance in the pharmaceutical environment. You will act as a consultant for business units and technical teams, supporting them in GxP-compliant software development and system validation.

Your tasks include developing validation and qualification concepts as well as ensuring compliance with regulatory requirements according to GAMP 5 standard. You will conduct risk analyses, support requirements management, and create extensive validation documentation such as Validation Plans, Risk Assessments, and Traceability Matrices. Furthermore, you will evaluate Data Integrity, Change Control, and Configuration Management processes and prepare for audits and inspections.

For this position, you need several years of experience in the pharmaceutical industry, particularly in software development or validation environments. Sound knowledge of GAMP 5, Computerized System Validation (CSV), Computer Software Assurance (CSA), and risk-based validation is required. You should have practical experience in SaaS lifecycle management and with cloud-based solutions, as well as be proficient in handling regulatory requirements such as EU GMP Annex 11 and FDA 21 CFR Part 11.

Familiarity with audit, compliance, and inspection processes, as well as fluent English skills, both written and spoken, are necessary. The position is remote and offers the opportunity to contribute to future-oriented projects in a dynamic environment.

Project details

• Start: 23.11.2026
• Remote: onsite
• Location: Darmstadt, DE
• Languages: German