Senior QA with enthusiasm for projects and validation
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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 Organisations (CMOs)? Then you can look forward to a leading role where your efforts can make a positive and direct difference every day.
You will participate in various projects within Drug Product and Finish Products or Active Pharmaceutical Ingredients (API) and Drug Substance 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 the project QA in product transfers from Novo Nordisk to Contract Manufacturing Organisations (CMOs). You will participate in various projects within Drug Product and Finish Products or Active Pharmaceutical Ingredients and Drug Substance working with both internal and external business partners. The QA role includes: The quality responsibility for the technical transfer to the CMOs and taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil 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 documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation. Expected travel is around 20 days a year as the Contract Manufacturing Organisations (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 preferably have minimum 4 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, validation and GMP requirements. We look for a candidate who: Has a natural ability to take lead and work as a team player, and proactively contributes to the team’s tasks and activities. Has the ability to work in an international set-up with external stakeholders with different interests and agendas. Meets own deadlines and knows how to prioritise between different tasks in an everchanging environment. Has great communication and collaboration skills and speaks and writes Danish and English fluently. About the department
The GCM QA area is responsible for quality assurance and quality support to outsourced production activities worldwide.
GCM QA is a dynamic area consisting of 70 competent people divided into 8 teams and departments with focus on either operations or projects. You will be a strong player in the project QA department. The department is characterised 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 prioritise to make room for fun at work. We have weekly quizzes, and we strive to have regular workout sessions to ensure on-going well-being in the team.
Working at Novo Nordisk
At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.
Contact
For further information, please contact Lene Cletus Petersen on +45 3079 0412.
Deadline
11th December 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.
You will participate in various projects within Drug Product and Finish Products or Active Pharmaceutical Ingredients (API) and Drug Substance 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 the project QA in product transfers from Novo Nordisk to Contract Manufacturing Organisations (CMOs). You will participate in various projects within Drug Product and Finish Products or Active Pharmaceutical Ingredients and Drug Substance working with both internal and external business partners. The QA role includes:
Qualifications You hold an academic degree as Pharmacist, Engineer or similar and preferably have minimum 4 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, validation and GMP requirements. We look for a candidate who:
The GCM QA area is responsible for quality assurance and quality support to outsourced production activities worldwide.
GCM QA is a dynamic area consisting of 70 competent people divided into 8 teams and departments with focus on either operations or projects. You will be a strong player in the project QA department. The department is characterised 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 prioritise to make room for fun at work. We have weekly quizzes, and we strive to have regular workout sessions to ensure on-going well-being in the team.
Working at Novo Nordisk
At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.
Contact
For further information, please contact Lene Cletus Petersen on +45 3079 0412.
Deadline
11th December 2023 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 30.8.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Bagsværd
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