GMP Professional - Kalundborg, Danmark - Novo Nordisk

Beskrivelse

The position

As our GMP Professional, you will have a holistic view in ensuring a high level of quality and compliance within BRD QC.

This will involve setting appropriate standards to maintain our Quality Management System (QMS), enabling us to meet all relevant GMP requirements.

Whilst working closely with stakeholders within the department and the GMP network, you will have a focus on driving and setting direction for quality in the department.

You will be responsible for:
Ensuring high-level GMP overview and report quality trends to management. Supporting daily operations and trends and ensure the relevant level of GMP in the organisation. Driving preparation for and follow-up on authority inspections and internal audits and participation. Leading and coordinating critical quality issues and compliance activities in the department and across if necessary. Handling deviations, investigations, quality processes, sparring with stakeholders on questions and challenges. In this position, you will have a high level of independence, guiding and teaching the department, colleagues, and management.


Qualifications Your experiences include:

A degree in pharmacy, biochemistry, production engineering or similar with several years of experience in the pharmaceutical industry with GMP.

A strong understanding of GMP regulations and requirements. Stakeholder management with experience in setting direction, guiding/ coaching. Experience with deviations, investigations and inspections. Excellent communication and interpersonal skills. Full proficiency in Danish and English.

On a personal level, you see yourself as being self-motivated, can work independently, proactive, solution-oriented and can work systematically to strive for simplicity in processes.

You enjoy collaborating and communicating with others, thrive building networks and working with individuals at all levels of the organisation to help set clear direction.

About the department QC is the part of BRD, where we are responsible for supporting the production with chemical and microbiological analyses.

In this way, we ensure that our life-saving medicine for people with serious chronic diseases always has the right, high quality.

We are more than colleagues located in Gentofte, Hillerød, and Kalundborg.

We drive improvements and innovation by, for example, working with Industry 4.0 to make the process faster and more seamless for the benefit of patients.

You will be part of the BRD QC department in Kalundborg, where the position is located and part of a cross functional GMP Team in BRD QC.

Working at BRD, Novo Nordisk 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 Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk.

We are app. colleagues committed to drive change for people with serious chronic diseases.

We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe.

Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone.

Are you ready for a life-changing career?