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Software Quality Assurance Specialist
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We are seeking a skilled Software Quality Assurance Specialist to contribute to the development of high-quality computerized systems.
Key Responsibilities:- Develop and review validation documentation in line with regulatory requirements and internal quality policies, ensuring compliance with industry standards.
- Conduct software compliance assessments (e.g., 21 CFR Part 11, Data Integrity) to ensure systems meet regulatory requirements, including familiarity with 21 CFR 820 and ISO 13485 regulations.
- Maintain and continuously improve the quality and compliance status of associated procedures and work instructions, ensuring accuracy in all deliverables.
- Monitor and report key quality metrics, identify trends, and drive continuous improvement initiatives, demonstrating effective time management and organizational skills.
- Support audits and regulatory inspections by providing validation documentation and quality assurance insights, ensuring a smooth process.
- Collaborate effectively with cross-functional teams, guiding them on validation tasks and ensuring alignment with best practices.
- A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
- Hands-on experience with computer system validation deliverables.
- Familiarity with 21 CFR 820 and ISO 13485 regulations; pharmaceutical validation experience may also be considered.
- Family health insurance
- Excellent pension scheme
- Life assurance
- Career development opportunities
- State-of-the-art facility
