Experienced GMP Partner

2 weeks ago

Søborg, Denmark Novo Nordisk Full time

The position

As our new Experienced GMP Partner, you will join a newly established team of professionals where you will have the opportunity to shape your role and develop it according to your unique strengths. In the area of Site Support and Improvements, we play a crucial role in boosting production capacity at Novo Nordisk, resulting in high demand for our services. Our primary deliverables are documents, making process optimizations within this area a key focus for your role. You will be working to ensure a high level of quality and compliance in our area by setting high standards in maintaining our Quality Management System (QMS), through ensuring that the department continuously delivers on all relevant GMP requirements and improving employee's quality mindset. GMP Partner is a newly created role in the area, hence part of your role will be to define and establish the position. Moreover, you will also be a member of the GMP network within the Injectable Finished Products Manufacturing Development (IFP ManDev) department. In collaboration with your peers in other areas, you will tackle tasks and challenges that span across different areas, such as inspection preparation, implementation of new systems or procedures, etc. Your job will be characterized by a dynamic blend of setting strategic direction, follow-up, and participation in management-related activities, 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. Your responsibilities will include: Ensure a high level of quality and compliance in our area by working with a quality mindset and optimizing Quality KPIs for timely deliverables Drive preparation for and follow-up on authority inspections and internal audits, ensuring a smooth process for supporting sites during inspections Lead and coordinate critical quality issues and compliance activities within the area and across organizations Drive process and delivery to Quality Management Review (QMR) and Risk process, supporting daily operations and maintaining a high level of GMP in the department, while also supporting and challenging deviations and change requests Qualifications To succeed in this role, you have: A MSc Degree in pharmacy, biochemistry, production engineering or similar Solid experience with GMP, compliance and documentation 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 Professional proficiency in English As an individual, you radiate a positive, cooperative, action-oriented, and solution-focused approach. You work systematically, logically, and proactively. You thrive on working with and across all levels of the organization, and your excellent collaboration and communication skills enable you to set direction, be solution-oriented, and work proactively. You strive for simplicity in processes and take pride in involving stakeholders closely in solving tasks and challenges. About the department The Injectable Finished Products (IFP), Site Support and Improvements (SSI) area is a dynamic, -employee area that provides site support and improvement projects of diverse complexity across our global production sites. The department is anchored by a high level of product knowledge and process understanding. As an Experienced GMP Partner in the SSI area, you will be part of a newly established team. Our ambition is to provide the best support to "line of business" with high levels of engagement and a good, social working environment. 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.

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