GMP Coordinator

at  Novo Nordisk

GMP Coordinator
Category: Quality
Location:Gentofte, Capital Region of Denmark, DK
Do you have a knowledge of Good Manufacturing Practice (GMP), and are you motivated by setting high compliance standards and ensuring that we continuously improve our processes and ways of working? Do you gain energy from collaboration with many colleagues and by succeeding together?
If so, you might be our new GMP Coordinator in the filling department. Apply now for a life-changing career!

QUALIFICATIONS

We are looking for someone with a strong quality-mindset who proactively takes initiatives and secures commitment from the stakeholders.

To succeed in this role, we expect you to have:

• An Academic Degree within pharmacy, biology, engineering, or similar field.
• At least +4 years of experience in the pharmaceutical or medical device industry, or a related field, with a specific focus on GMP regulated areas and complex production processes; experience from an isolator filling line is an advantage.
• The ability to think and act with a broad perspective, encompassing the big picture while maintaining focus on and interest in crucial details.
• LEAN mindset with experience in systematic problem solving is considered an advantage
• Professional proficiency in both Danish and English.

As an individual, you exhibit a positive, cooperative attitude and approach tasks with a solution-focused mindset. You work systematically, logically, and proactively. Your effective communication extends across all levels of the organization, from operators to management, and you take pride in resolving tasks and challenges with a hands-on approach, involving key stakeholders closely in the process.

Work tasks will include, but are not limited to:

• Driving the preparation for and overseeing the follow-up on authority inspections and internal audits
• Coaching and assisting your colleagues in GMP-related tasks such as deviations, changes, projects etc.
• Prepare and/or approve trend reports, Quality Oversight Tools, Quality Management Review (QMR)
• Maintaining a high-level GMP overview and reporting on GMP and quality trends to managemen

To succeed in this role, we expect you to have:

• An Academic Degree within pharmacy, biology, engineering, or similar field.
• At least +4 years of experience in the pharmaceutical or medical device industry, or a related field, with a specific focus on GMP regulated areas and complex production processes; experience from an isolator filling line is an advantage.
• The ability to think and act with a broad perspective, encompassing the big picture while maintaining focus on and interest in crucial details.
• LEAN mindset with experience in systematic problem solving is considered an advantage
• Professional proficiency in both Danish and English