QA Validation Specialist (m/f/d)

Key Responsibilities

• Perform QA oversight of validation, qualification, and review activities to ensure GMP equipment, facilities, and systems are continuously maintained in a validated state.

• Schedule and prioritize personal tasks as well as tasks for junior team members under the guidance of the Validation Manager.

• Conduct change control assessments for GMP equipment, facilities, and systems to ensure all validation activities comply with regulatory requirements.

• Develop and review validation protocols and reports, including Installation Qualifications (IQ), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping of controlled storage rooms and equipment.

• Review and approve SOPs, protocols, reports, change controls, deviations, and other quality records, providing strong technical expertise and ensuring compliance with global standards.

Must-Have Qualifications

• Bachelor’s degree in Science or Technical discipline.

• 2–6 years of work experience in the pharmaceutical industry, preferably in a GMP environment.

• Thorough understanding of Cell and Gene therapy manufacturing equipment, facility systems, and validation procedures.

• Experience with Quality Systems such as Document Management Systems (DMS), Laboratory Information Management Systems (LIMS), Validation and Qualification Management Systems (e.g., Kneat), and Trackwise (Change Control, Deviations, CAPA).

• Strong organizational and communication skills, with the ability to manage multiple tasks and collaborate effectively across teams.