GMP Coordinator

Job title:

GMP Coordinator

Company:

Novo Nordisk

Job description

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:GMP CoordinatorCategory: ManufacturingLocation:Hillerød, Capital Region of Denmark, DKAre you intrigued by the opportunity to play a pivotal role in a new capacity expansion project that will influence and impact future Active Pharmaceutical Ingredient (API) production facilities?Do you have a passion for establishing structured standards and a proven track record in monitoring and handling GMP documentation?If so, this is an excellent chance to join a team where ideas are transformed into actions. Apply today for the position as our GMP Coordinator in a new large green field project based in Hillerød!The position
In Product Supply API we are expanding our production facilities in Hillerød, to meet the future needs of our growing product pipeline. Therefore, we are seeking a GMP Coordinator to be part of the executing Project Quality Management (PQM) work package for the new API facility in Hillerød.In this position, you will be responsible for monitoring quality related activities during the project and supporting in setting the standards for quality setup in the future production. You will also be the go-to person for quality related topics and questions across the project. Additionally, you will be involved in monitoring the quality deliverables and establishing the monitoring setup for the future production.The day-to-day activities related to the role include (but are not limited to):

• Supporting in setting quality standards for the department and ensuring that the quality system is complies with regulatory requirements.
• Reporting and evaluating on trending.
• Quality monitoring setup and reporting (KPIs).
• Build the future GMP coordination/monitoring setup for the future 25L operation.

As a GMP Coordinator, you will be part of ensuring that our commissioning/qualification/validation documentation complies with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).QualificationsYour experiences include:

• A scientific academic degree in engineering, biology, chemistry, or similar.
• 3+ years of experience within GMP, preferably within the role of GMP Coordinater.
• Handling data/ data analysis and communicating findings in a simplistic way across stakeholders. Experience with Excel is desirable.
• Experience in cross-functional communication and stakeholder management.
• Fluent in spoken and written English.

On a personal level, you have a problem-solving mindset, with the ability to manage timeliness and priorities. You enjoy teamwork and working in a multicultural environment, with the ability to also work independently. Your personal drive, focus on building structure, implementing improvements, and the ability to execute independently and proactively will ensure that value is added where it matters within deadlines.Furthermore, you have excellent communication skills, with the ability to build relationships and ensure trust and commitment from all stakeholders. You can make decisions that balance quality requirements, authority expectations, and business needs.About the department
Our team is working to expand API capacity of our Biotech production in Hillerød. You will become a part of one of the most significant expansion projects in Novo Nordisk – and when finished the facility will employ app. 340 colleagues. The highly automated facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. It will expand our capacity for our portfolio of clinical late phase products to serve more people living with serious chronic diseases including rare diseases.

At Novo Nordisk we do not only drive change for our patients – we also cultivate life-changing careers for our employees by fostering a learning culture with high levels of trust, innovation, and development throughout the organisation. To steer the project and reach the initial phase of production, we need your help! Are you ready to join the project team and our journey?Working at PS API Expansion, Novo Nordisk
You will be joining PS API Expansions. The area is anchored in Novo Nordisk Product Supply, Quality & IT, which globally employ approximately 30,000 of Novo Nordisk’s 64,000 employees.PS API Expansions is a newly established and growing area with the responsibility to design, plan and build all major API Expansions projects across Novo Nordisk to serve the needs of millions of patients.We build and design our future API facilities as multi-product facilities with flexibility to accommodate future processes and display state-of-the-art technology and working environment. We focus on delivering the highest quality to patients globally in an efficient and environmentally sustainable way.We are setting the standards for the future, designing facilities we will still be proud of many decades from now. We drive world class execution of capacity projects, and together we are building the future of Novo Nordisk.Contact
If you would like to discuss further, you are welcome to contact Martin Rosenkjær (Project Manager) at: +45 34 48 32 48.Deadline
4 August 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.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Sun, 14 Jul 2024 01:23:25 GMT

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