Quality Assurance Manager
5 days ago
About the Job:
We are looking for a qualified Quality Assurance Manager - Validation to join our team at TN Sweden. As a Quality Assurance Manager, you will be responsible for ensuring that our validation processes meet the required specifications and are compliant with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and Implement Validation Plans: Collaborate with cross-functional teams to design, implement, and maintain comprehensive validation plans 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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