Senior QA Professional (Denmark, Høje-Taastrup)

Jobbeskrivelse
Placering
Høje-Taastrup, Denmark

Jobkategori
Quality

Ansøg nu

Are you looking for a place to feed your enthusiasm for quality? And are you excited about playing a crucial role in ensuring quality processes in Novo Nordisk’s global network of Contract Manufacturer Organizations (CMOs)? If so, then read on and apply today for a life-changing career!

The position
In this position, you will be the project QA in product transfers from Novo Nordisk to Contract Manufacturing Organizations (CMOs. You will participate in various projects within Active Pharmaceutical Ingredients (API) and starting material etc.. You will work with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks.

The QA role includes:

• The quality responsibility for the technical transfer to the CMOs and taking the lead in ensuring the CMO Quality Management System (QMS) is compliant with fulfilling relevant GMP requirements.

• Negotiation and implementation of quality agreements, approving process validation strategy and related documents as well as setting up the QA processes for commercial manufacturing. You are also expected to participate in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs.

• Manage quality issues during the technical transfer: Process validation documentations, deviations, out of specifications, change controls, action plans and follow ups, evaluate production documentations.

• Expected travel is around 20 days a year as the Contract Manufacturing Organizations (CMOs) are located outside Denmark primarily Europe and US.

If you are looking for a job which can foster the development of your professional and personal competences, this is your opportunity.

Qualifications
To succeed in this role, you have:

• An academic degree as Pharmacist, Engineer or similar

• A few years of experience from the pharmaceutical industry either from production or QA

• Knowledge about quality, validation and GMP requirements

• Fluency In English

As a person you have a natural ability to take lead and work as a team player, and proactively contributes to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, meet own deadlines and knows how to prioritize between different tasks in an everchanging environment.

About The Department
The GCM QA Drug Substance area is responsible for quality assurance and quality support to outsourced production activities worldwide.

GCM QA DS is a dynamic area consisting of 35 competent people divided into 4 teams and departments with focus on either operations or projects. You will be a strong player in the project QA department. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our area is to deliver QA support and set direction for our global CMOs.

We focus on good social relations and prioritize to make room for fun at work. We have a great team spirit, and it is important for us that you will be a part of it.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease.

Contact
For further information, please contact Lotte Lammert Fick, QA Senior Manager +45 30759146.

Deadline
24 October 2024

We will review the applications and conduct interviews on an ongoing basis, so we encourage you to apply as soon as possible.

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.