
Compliance and Validation Specialist
5 days ago
About the Position:
We are seeking a skilled Compliance and Validation Specialist to join our quality assurance team at TN Sweden. In this role, you will be responsible for ensuring that our validation processes comply with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and Implement Compliance Strategies: Collaborate with cross-functional teams to design, implement, and maintain comprehensive compliance strategies that ensure compliance with regulatory requirements and industry standards.
- Coordinate Qualification and Commissioning Activities: Oversee the qualification and commissioning of equipment, processes, and systems to ensure they meet the required specifications and are ready for production.
- Participate in User Requirement Specification Development: Contribute to the development of user requirement specifications, risk analysis, and periodic reviews to ensure quality and compliance.
- Drive Continuous Improvement Initiatives: Identify areas for improvement and develop initiatives to enhance the efficiency and effectiveness of our validation processes.
- Maintain Expertise and Stay Up-to-Date: Stay current with industry developments, regulatory changes, and technological advancements to ensure our validation practices remain best-in-class.
Requirements:
- Technical or Scientific University Degree: A degree in a relevant field such as engineering, science, or technology.
- Over 10 Years of Experience: A minimum of 10 years of experience in the medical device or pharmaceutical industry, with a focus on validation management.
- Extensive Experience in Validation Management: Proven track record of success in leading and coordinating validation activities, including leadership and team coordination.
- Structured Approach to Work and Problem-Solving: A methodical approach to work and problem-solving, with a strong attention to detail and ability to analyze complex issues.
- Leadership Skills and Ability to Motivate Teams: Excellent leadership skills, with the ability to motivate and inspire teams to achieve high-quality results.
- Excellent Written and Verbal Communication Skills: Strong written and verbal communication skills, with proficiency in Swedish and English.
- Proficiency in Statistical Tools and Validation of Computerized Systems: Familiarity with statistical tools and the validation of computerized systems according to GAMP5 guidelines.
BENEFITS:
- Meaningful Impact: Contribute to the development and implementation of high-quality validation processes that make a meaningful impact in people's everyday lives.
- Career Growth Opportunities: Opportunities for career growth and professional development within our company.
- Collaborative Team Environment: Join a collaborative team environment where your contributions are valued and recognized.
- Professional Challenge: Take on new challenges and opportunities to expand your skills and expertise.
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