Specialist Quality Assurance - R&D (m/f/d)

2024-12-27

We are seeking an experienced QA Specialist - R&D (m/f/d) to support our R&D QA department in ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations. The successful candidate will review validation documents, perform audits, and provide guidance on compliance of computerized systems as well as on preclinical and clinical studies in a regulated environment. Key Responsibilities: - Serve as the primary QA contact for local R&D functions and IT regarding the implementation and validation of digital solutions and computerized systems. - Support digitalization by reviewing qualification and validation documents. - Provide expert guidance on policies and regulatory requirements in project teams. - Collaborate and communicate with stakeholders and global team members. - Conduct and manage audits for compliance with GLP and GCP regulations, specifically for clinical and preclinical studies. - Support during regulatory inspections and conduct supplier audits as required. - Develop and conduct training on compliance-related topics. Qualifications & Competencies: - Bachelor’s or Master’s degree in Life Sciences, Information Technology, or a related field. - Minimum 3 years of experience in regulated GxP environment and QA auditing. - High affinity for digital solutions and technical knowledge of industry IT topics. Understanding of computerized systems validation and SDLC is a pro. - Mindset that demonstrates confidence, resourcefulness, and proactive action. - Demonstrated ability to work as both a team player and independently. - Innovative problem-solving, critical thinking, compliance knowledge, and high affinity for documentation requirements in regulated industry. Benefits: - Flexible working hours (37.5 hours/week) and an attractive company pension scheme. - Competitive salary package: 13 monthly salaries + holiday pay + target bonus. - 30 days holiday entitlement. - Hybrid working model (up to 50% remote). - Internal training and promotion opportunities. - International cooperation opportunities. - Training on the job. - Contributions of ideas to process design. - Exposure to the development of veterinary medicinal products. - Corporate benefits, free (electric) car parking, good company canteen, and a health management program. The company emphasizes the importance of diversity and inclusion, urging candidates of different backgrounds to apply. They uphold values of innovation through diverse ideas and collaboration within an inclusive workplace.

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