Validation Process Lead

5 days ago


Uppsala, Uppsala, Sweden TN Sweden Full time

About the Position:

We are seeking an experienced Validation Process Lead to join our quality assurance team at TN Sweden. In this role, you will lead the development and implementation of validation plans, strategies, and test protocols for new investments and production updates.

Responsibilities:

  1. Lead Cross-Functional Teams: Collaborate with cross-functional teams to design, implement, and maintain comprehensive validation plans that ensure compliance with regulatory requirements and industry standards.
  2. Oversee Qualification and Commissioning Activities: Supervise the qualification and commissioning of equipment, processes, and systems to ensure they meet the required specifications and are ready for production.
  3. Contribute to User Requirement Specification Development: Participate in the development of user requirement specifications, risk analysis, and periodic reviews to ensure quality and compliance.
  4. Develop Continuous Improvement Initiatives: Identify areas for improvement and develop initiatives to enhance the efficiency and effectiveness of our validation processes.
  5. Stay Current with Industry Developments: 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.
  • Methodical Approach to Work and Problem-Solving: A structured approach to work and problem-solving, with a strong attention to detail and ability to analyze complex issues.
  • Excellent Leadership Skills: Excellent leadership skills, with the ability to motivate and inspire teams to achieve high-quality results.
  • Strong Written and Verbal Communication Skills: Strong written and verbal communication skills, with proficiency in Swedish and English.
  • Familiarity with Statistical Tools and Validation of Computerized Systems: Familiarity with statistical tools and the validation of computerized systems according to GAMP5 guidelines.

WHAT YOU'LL BE DOING:

  • Leading Cross-Functional Teams: Collaborate with cross-functional teams to develop and implement validation plans.
  • Coordinating Qualification and Commissioning Activities: Oversee the qualification and commissioning of equipment, processes, and systems.
  • Conducting User Requirement Specification Development: Participate in the development of user requirement specifications.
  • Developing Continuous Improvement Initiatives: Identify areas for improvement and develop initiatives to enhance the efficiency and effectiveness of our validation processes.
  • Staying Current with Industry Developments: Stay current with industry developments, regulatory changes, and technological advancements.


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