GMP Coordinator

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 Assembly and Packaging department, in Kirke Værløse and Gentofte. Apply now and join us! The Position As GMP Coordinator you will collaborate closely with management and support teams in upholding and enhancing a high level of Good Manufacturing Practice (GMP). 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 trend reports, Quality Oversight Tools, Quality Management Review (QMR)

Maintaining a high-level GMP overview and reporting on GMP and quality trends to management

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. 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 BRD FP.

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:

BSc or MSc 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.

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.

Professional proficiency in both Danish and English.

As an individual, you are positive, cooperative, action-oriented, and work with a solution-focused approach. You work systematically, logically, and proactively. Your effective communication spans all levels of the organization, from operators to management, and you take pride in resolving tasks and challenges with a hands-on approach, involving a great variety of key stakeholders closely in the process. 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 by going on the shopfloor and interact with production.

About the Department Site Kirke Værløse is part of Biotech & Rare Disease FP (Finished Products) with +120 people employed. Besides Kirke Værløse sites is placed in Gentofte, Kalundborg and Taastrup where we are more than 350 colleagues working together to ensure that our finished products are assembled and packed to the highest standards before distributed to people living with serious chronic diseases. We bring value to our patients by delivering high-quality products in accordance with Good Manufacturing Practice (GMP) in a timely and cost-effective way as we constantly optimize our processes and invest in the latest technology. Working at BRD, [xxxxx] Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all [xxxxx] products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for [xxxxx]. We are more than 3400 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support [xxxxx]'s initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact For further information, please contact CVP GMP Partner, Cathrine Richnagel, at +[xxxxx]or Director, Rasmus Herschend, at +[xxxxx].

Deadline 23 June 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. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.