QA Validation Specialist

A leading organization in the pharmaceutical and medical device industries dedicated to ensuring highest standards of quality, safety, and compliance across all operations. They focus on innovative solutions and rigorous quality assurance processes to support global healthcare initiatives.

We are seeking a detail-oriented QA Validation Specialist to oversee validation activities related to equipment, packaging, and master data management within a GMP environment. This role involves ensuring compliance with regulatory standards, reviewing validation documents, and supporting quality improvement initiatives in manufacturing processes.

• Provide QA oversight for equipment validation, packaging qualification, and process validation activities.
• Review and approve validation documentation, ensuring adherence to corporate, site, and regulatory requirements.
• Support testing strategies and conduct investigations into quality issues.
• Manage master data in the PASX electronic batch record system, ensuring accuracy and compliance.
• Review and approve changes related to equipment parameters, device management, and automation systems, including device responsibilities under GMP regulations.
• Perform final reviews of technical change controls, confirming stakeholder assessments are complete and accurately documented.
• Act as QA contact for deviation records and manage non-conformance incidents.
• Collaborate with manufacturing, engineering, and quality teams to maintain GMP standards and continuous process improvements.

• Bachelor's degree in Life Sciences, Process Technology, or a related field, or equivalent experience.
• At least 3 years of relevant experience in the pharmaceutical or medical device industry, particularly in validation and automation systems.
• Strong knowledge of GMP, equipment validation, and computer compliance standards.
• Experience with deviation and change control processes.
• Fluent in English, with excellent communication and documentation skills.

Apply to our vacancy for more information. Looking forward to getting in touch!

57080

€50000.00 - €70000.00 monthly