Advanced QA Professional within Global Contract Manufacturing

at  Novo Nordisk

Advanced QA Professional within Global Contract Manufacturing
Category: Quality
Location:Bagsværd, Capital Region of Denmark, DK
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 Manufacturing Organizations (CMOs)?
Then you can look forward to a QA role in Global Contract Manufacturing Drug Substance (GCM DS) where your efforts can make a positive and direct impact for the patients every day.
You will participate in the Quality Oversight of our CMO´s for Active Pharmaceutical Ingredients (API) and Drug Substance (DS) and you will be working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks.

THE POSITION

In this position you will be responsible for Quality Assurance of Contract Manufacturing and will be responsible for one or more CMO´s with various products being produced for Novo Nordisk.

The QA role includes:

• The quality responsibility for ensuring that our products are manufactured according to cGMP and our Marketing Authorizations.
• Numerous encounters daily with both internal and external business partners and a high level of complexity in your daily tasks. You should also contribute to continuous improvements of our processes and strive for simplicity without compromising quality.
• Handling of documentation from the contract manufacturers is a part of the job and you are also expected to participate in audits performed at the CMO and ensure sufficient follow up on CAPAs.
• QA support and GMP guidance to our partners and final release of the products from CMO`s to the further process in Novo Nordisk.
• Expected travel is around 10-15 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

You hold an academic degree as Pharmacist, Engineer or similar and have minimum three years of experience from the pharmaceutical industry either from production or QA, where you have gained a solid and up-to-date knowledge of quality and GMP requirements.

To succeed in this role you should:

• Hold an academic degree as a Pharmacist, Engineer, or similar.
• Possess a minimum of three years of experience in the pharmaceutical industry, preferably in production or QA.
• Have gained a solid and up-to-date knowledge of quality and GMP requirements.
• Have great communication and collaboration skills and speaks and writes English fluently.

As a person, you have a natural ability to take responsibility and work as a team player, proactively contributing to the team’s tasks and activities. Additionally, you have the ability to work in an international set-up with external stakeholders who may have different interests and agendas. Furthermore, you meet your own deadlines and understand how to effectively prioritize between different tasks in an ever-changing environment

The QA role includes:

• The quality responsibility for ensuring that our products are manufactured according to cGMP and our Marketing Authorizations.
• Numerous encounters daily with both internal and external business partners and a high level of complexity in your daily tasks. You should also contribute to continuous improvements of our processes and strive for simplicity without compromising quality.
• Handling of documentation from the contract manufacturers is a part of the job and you are also expected to participate in audits performed at the CMO and ensure sufficient follow up on CAPAs.
• QA support and GMP guidance to our partners and final release of the products from CMO`s to the further process in Novo Nordisk.
• Expected travel is around 10-15 days a year as the Contract Manufacturing Organizations (CMOs) are located outside Denmark primarily Europe and US

To succeed in this role you should:

• Hold an academic degree as a Pharmacist, Engineer, or similar.
• Possess a minimum of three years of experience in the pharmaceutical industry, preferably in production or QA.
• Have gained a solid and up-to-date knowledge of quality and GMP requirements.
• Have great communication and collaboration skills and speaks and writes English fluently