Welcome to Novo Nordisk, a global healthcare company with a passion for improving the lives of millions of people worldwide. We are currently seeking a dynamic and experienced Validation Lead to join our team and contribute to our mission of changing diabetes and other serious chronic diseases. As a Validation Lead, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes in accordance with regulatory guidelines. This is an exciting opportunity for a driven and detail-oriented individual with a strong background in validation and a passion for making a difference in the world of healthcare. If you have the necessary qualifications and a desire to be a part of a company that is dedicated to making a positive impact, we encourage you to apply for this role.
- Develop and maintain validation strategies and plans for Novo Nordisk's manufacturing processes.
- Ensure compliance with regulatory requirements and industry standards for validation.
- Lead validation activities for new products, processes, and equipment.
- Conduct risk assessments and gap analyses to identify potential validation issues.
- Collaborate with cross-functional teams to ensure timely completion of validation activities.
- Develop and maintain validation protocols and reports.
- Review and approve validation documentation, including protocols, reports, and deviations.
- Conduct training for team members on validation procedures and requirements.
- Monitor and track validation progress and provide regular updates to management.
- Troubleshoot and resolve any validation issues that arise during the manufacturing process.
- Ensure the accuracy and integrity of all validation data and documentation.
- Keep up-to-date with industry trends and changes in regulatory requirements related to validation.
- Continuously improve validation processes and procedures to enhance efficiency and compliance.
- Communicate effectively with internal and external stakeholders to ensure successful validation outcomes.
- Uphold Novo Nordisk's values and standards of quality and excellence in all validation activities.
Extensive Experience In Validation: The Ideal Candidate For A Validation Lead Position At Novo Nordisk Will Have A Minimum Of 5 Years Of Experience In Validation, With A Strong Background In Pharmaceutical Or Biotech Industries. They Should Have A Thorough Understanding Of Fda Regulations And Guidelines, As Well As Knowledge Of Industry Best Practices.
Strong Leadership Skills: A Validation Lead At Novo Nordisk Must Have Excellent Leadership Skills To Guide And Manage A Team Of Validation Specialists. This Includes The Ability To Delegate Tasks, Provide Clear Direction, And Motivate Team Members To Achieve Project Goals.
Excellent Communication And Interpersonal Skills: The Role Of A Validation Lead Requires Effective Communication With Various Stakeholders, Including Project Managers, Engineers, Quality Assurance, And Regulatory Personnel. The Ideal Candidate Should Possess Strong Interpersonal Skills To Effectively Collaborate And Build Relationships With These Stakeholders.
Attention To Detail: As A Validation Lead, Attention To Detail Is Crucial To Ensure That All Validation Activities Are Conducted Accurately And In Compliance With Regulatory Requirements. This Includes Reviewing And Approving Protocols, Reports, And Other Validation Documentation.
Project Management Skills: A Validation Lead At Novo Nordisk Must Be Able To Effectively Manage Multiple Projects And Timelines Simultaneously. This Requires Strong Project Management Skills, Including Planning, Organizing, And Overseeing Project Activities To Ensure Timely Completion. The Candidate Should Also Be Able To Identify And Mitigate Potential Risks And Issues That May Impact Project Timelines.
Quality Assurance
Process Improvement
Project Management
Data Analysis
GMP Knowledge
Change control
Team Leadership
Technical
Compliance Management
Risk assessment
Documentation management
Validation Strategy
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Validation Lead in 2880 Bagsværd, Denmark is between 50,000-80,000 DKK per month. This may vary depending on the specific company, experience level, and responsibilities of the role.
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Novo Nordisk AS engages in the research, development, manufacture, and marketing of pharmaceutical products. It operates through the Diabetes and Obesity Care; and Biopharmaceuticals segments. The Diabetes and Obesity Care segment covers insulins, glucagon-like-peptide 1, other protein-related products, oral anti-diabetic drugs and obesity. The Biopharmaceuticals segment handles the research, development, manufacture, and distribution of products within the areas of haemophilia, growth hormone, hormone replacement, inflammation and other therapy areas.
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