Advanced Analytical Professional

Category: Manufacturing

Location:Bagsværd, Capital Region of Denmark, DK

• Define and execute validation and qualification strategies for Gx P Computerized Systems, Computerized Equipment, and Emerging Tech such as novel spectroscopic equipment
• Manage end-to-end validation and qualification activities, including creating validation plans, validation reports, design reviews, test strategies, and execution.
• Ensure systems comply with relevant internal and external regulatory requirements.
• Participate in audits and inspections, providing solutions to compliance gaps identified in these processes.
• Analyze, design, implement, operate, deploy, and support the organization’s IT resources, including computer hardware, operating systems, communications, software applications, data processing, and security.
• Develop equipment strategies, policies, and plans, and maintain and use IT resources effectively, as well as train and support equipment users and maintainers. Also, qualify new types of equipment for new analytical methods and implement strategies and manage laboratory operations for analytical equipment.

• M.Sc. in Life Science, Engineering or similar.
• 5+ years of experience with Gx P Pharma production, preferably within analytical equipment.
• Knowledge about qualification of analytical equipment.
• Experience with driving optimization projects using LEAN.
• Good collaboration and communication skills.
• Can-do attitude.
• Strong written and oral English skills.

• Experience in method development and validation.
• Understanding of regulatory requirements.
• Experience with LIMS and Empower IT systems.
• Strong stakeholder engagement abilities.