Senior Validation Consultant

5 days ago


Uppsala, Uppsala, Sweden TN Sweden Full time

About the Role:

We are seeking a highly skilled Senior Validation Consultant to join our team at TN Sweden. As a key member of our quality assurance department, you will be responsible for developing and implementing validation plans, strategies, and test protocols for new investments and production updates.

Key Responsibilities:

  1. 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.
  2. 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.
  3. Participate in User Requirement Specification Development: Contribute to the development of user requirement specifications, risk analysis, and periodic reviews to ensure quality and compliance.
  4. Drive Continuous Improvement Initiatives: Identify areas for improvement and develop initiatives to enhance the efficiency and effectiveness of our validation processes.
  5. 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 OF THIS ROLE:

  • 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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