QA Validation Consultant

For an international veterinary pharmaceutical company, we are looking for an experienced QA Validation Expert / SME to support a GMP-regulated transfer and packaging project environment.

The project focuses on the transfer of sterile manufacturing processes as well as the implementation and qualification of new sustainable primary packaging solutions. The main focus of the role is the GMP-compliant support of qualification, validation and transfer activities within the project team

Zu besetzendes Projekt: QA Validation Consultant

Branche: Biotech

Fähigkeiten: Quality Assurance Engineer,Injection Packaging

Projektstart: 01.06.2026

Projektdauer: 6 months

Einsatzort: Niedersachsen, Deutschland

Responsibilities include:

• QA support of qualification and validation activities
• Review and assessment of GMP-relevant documentation (e.g. IQ/OQ/PQ, FAT/SAT, risk assessments)
• Support of Change Controls, Deviations and CAPAs
• Participation in activities related to sterilization, decontamination and manufacturing processes
• GMP-compliant collaboration with Engineering, Production, Laboratories and Quality Assurance
• Technical support and consulting within the project environment

The project scope includes:

• Cleanrooms and pharmaceutical production areas
• Utilities and production equipment
• Sterilization and decontamination processes
• Packaging systems and new primary packaging materials
• Process and method validations

We are looking for a hands-on GMP / Validation expert with experience in pharmaceutical environments, ideally within sterile manufacturing, qualification and validation. The role is designed as an operational SME function within the project team and not as a traditional project management position.