Senior QA with enthusiasm for projects and validation
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We would enjoy welcoming a straightforward person with a good sense of humour to our department. So, are you looking for a place to feed your enthusiasm for quality? Are you excited about playing a crucial role in ensuring quality processes in Novo Nordisk’s global network of Contract Manufacturer Organisations (CMOs)? Most important, are your eager to contribute your energy to a diverse team that works hard to bring benefits to our patients and stakeholders? 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 working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Since you will be working in a global environment, you will get the opportunity to travel to sites outside Denmark. Working in our team you will have both great professional and personal development opportunities in a well-functioning department. We can offer you a great working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. The position
In this position you will be the QA in project transfers from Novo Nordisk to Contract Manufacturing Organisations (CMOs). You will participate in various projects working with both internal and external business partners 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 lead in ensuring the CMO Quality Management System (QMS) is sufficient to fulfil relevant GMP requirements. The quality responsibility for the technical transfer to the CMOs and taking lead in ensuring the CMO Quality Management System (QMS) is sufficient to fulfil relevant GMP requirements. Manage quality issues during the technical transfer: Deviations, out of specifications, change controls, action plan and follow up, evaluate product documentation. Negotiation and implementation of quality agreements, approving 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. Expected travel is around 25 days a year as the Contract Manufacturing Organisations (CMOs) are located outside Denmark. 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 some years of experience from the pharmaceutical industry either from production, QA, or QC where you have gained a solid and up-to-date knowledge of quality and GMP requirements. We are looking for an open-minded person with an outgoing attitude and natural networking skills, who can perform on different organisational levels. In addition, 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 2-3 years of experience Has validation experience 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
GCM QA is responsible for quality assurance and quality support to outsourced production activities worldwide.
GCM QA is a dynamic department consisting of 40 competent people divided into 4 teams with focus on either operations or projects. You will be a strong player in the project teams. The department is characterised by a high level of professionalism, flexibility, and cooperation. The primary role of our department 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 daily 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 Pia Bech Vince on +45 30792171.
Deadline
July 17th 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. Do you know someone?
If it is not the job for you, perhaps you know someone who might fit and be interested, please share this job. Thank you for your referral.
#LI-AMS1 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 working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Since you will be working in a global environment, you will get the opportunity to travel to sites outside Denmark. Working in our team you will have both great professional and personal development opportunities in a well-functioning department. We can offer you a great working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. The position
In this position you will be the QA in project transfers from Novo Nordisk to Contract Manufacturing Organisations (CMOs). You will participate in various projects working with both internal and external business partners 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 lead in ensuring the CMO Quality Management System (QMS) is sufficient to fulfil relevant GMP requirements.
Qualifications You hold an academic degree as Pharmacist, Engineer or similar and preferably have some years of experience from the pharmaceutical industry either from production, QA, or QC where you have gained a solid and up-to-date knowledge of quality and GMP requirements. We are looking for an open-minded person with an outgoing attitude and natural networking skills, who can perform on different organisational levels. In addition, we look for a candidate who
GCM QA is responsible for quality assurance and quality support to outsourced production activities worldwide.
GCM QA is a dynamic department consisting of 40 competent people divided into 4 teams with focus on either operations or projects. You will be a strong player in the project teams. The department is characterised by a high level of professionalism, flexibility, and cooperation. The primary role of our department 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 daily 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 Pia Bech Vince on +45 30792171.
Deadline
July 17th 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. Do you know someone?
If it is not the job for you, perhaps you know someone who might fit and be interested, please share this job. Thank you for your referral.
#LI-AMS1 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 27.3.2023, 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.
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