GMP Coordinator (Denmark, Gentofte)

Jobbeskrivelse
Placering
Gentofte, Denmark

Jobkategori
Quality

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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!

The position
As a GMP Coordinator you will collaborate closely with management and support teams in upholding and enhancing a high level of Good Manufacturing Practice (GMP). Your job will be characterized by a dynamic blend of coordination, follow-up, and setting direction, and driving actions and projects across the department alongside the focused execution of your own tasks. As a result, a flexible workstyle, and the ability to prioritize your tasks and time are essential qualities for this role.

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 management

Moreover, you will be a member of the GMP network within the CVP area that facilitate collaboration, alignment and sharing of best GMP-related practices across Product Supply Aseptic Manufacturing.
The position requires the ability to act as a role model in setting the direction. Furthermore, it is essential that you are curious to understand and gain energy from interacting with the production team on the shop floor.

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.

About the department
You will join the PS AM Gentofte HAC Aseptic Filling L6 department, a filling department currently in the project phase. We are an isolator filling line focusing on, and preparing for, handover to start production after the summer next year. As we ramp up, our focus will shift from a project perspective to a production driven department. This is a high-volume capacity 24/7 operation, supporting the launch of new product. The department are dedicated to achieving excellence in our processes and outcomes.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact
For further information please contact Anne Holm Andersen (Director) at [email protected].

Deadline
11 November 2024.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.