Senior QA Professional for Quality and Contract Manufacturing
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Do you enjoy collaborating with internal as well as external stakeholders using your solid QA expertise? 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 you eager to contribute your energy to a diverse team that works hard to bring benefits to our patients and stakeholders? 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
As QA Professional you will be responsible for quality assurance of contract manufacturing and will be responsible for one or more CMO`s. You will have to offer QA support and GMP guidance to out partners and do the final release to the API and intermediates from CMO's to the further process in Novo Nordisk. Also, you will be responsible for ensuring that our products are manufactured according to cGMP and our marketing authorisations.
You will have numerous encounters daily with both internal and external business partners and you should expect a high level of complexity in your daily tasks. You will solve a wide variety of tasks and have a great opportunity to be challenged every day. The daily QA activities are typically carried out by the contract manufacturers themselves, but the handling of documentation from the contract manufacturers is a part of the job.
Since the manufacturers are located outside Denmark, you are expected to travel 15-20 days a year.
Qualifications
You hold an academic degree as Pharmacist, Engineer or similar and have at least 4 years of experience from a pharmaceutical organisation where you have gained a solid and up-to-date knowledge of quality and GMP requirements i.e. Non-Conformity (NC), Corrective Actions and Preventive Actions (CAPA) handling, change control, complaints, Annual Product Review (APR) and validations.
The ideal candidate is Qualified Person (QP) delegate and/or has thorough knowledge of quality assurance of pharmaceutical manufactured products.
With your good cooperation and communication skills you are able to organise and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mind set and are a team player but are also able to work independently. You thrive on working across departments in an international organisation. Great communication skills are a must and you are expected to be fluent in Danish and English.
About the department
GCM QA is a dynamic department consisting of 60 competent people and 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 Contract Manufacturer Organisations worldwide. We focus on good social relations and well-being in the team and prioritise to make room for fun at work.
Contact
For further information, please contact Birgitte Madsen Find on +45 3075 4482.
Deadline
15 January 2023 Applications will be reviewed on-going. 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.
As QA Professional you will be responsible for quality assurance of contract manufacturing and will be responsible for one or more CMO`s. You will have to offer QA support and GMP guidance to out partners and do the final release to the API and intermediates from CMO's to the further process in Novo Nordisk. Also, you will be responsible for ensuring that our products are manufactured according to cGMP and our marketing authorisations.
You will have numerous encounters daily with both internal and external business partners and you should expect a high level of complexity in your daily tasks. You will solve a wide variety of tasks and have a great opportunity to be challenged every day. The daily QA activities are typically carried out by the contract manufacturers themselves, but the handling of documentation from the contract manufacturers is a part of the job.
Since the manufacturers are located outside Denmark, you are expected to travel 15-20 days a year.
Qualifications
You hold an academic degree as Pharmacist, Engineer or similar and have at least 4 years of experience from a pharmaceutical organisation where you have gained a solid and up-to-date knowledge of quality and GMP requirements i.e. Non-Conformity (NC), Corrective Actions and Preventive Actions (CAPA) handling, change control, complaints, Annual Product Review (APR) and validations.
The ideal candidate is Qualified Person (QP) delegate and/or has thorough knowledge of quality assurance of pharmaceutical manufactured products.
With your good cooperation and communication skills you are able to organise and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mind set and are a team player but are also able to work independently. You thrive on working across departments in an international organisation. Great communication skills are a must and you are expected to be fluent in Danish and English.
About the department
GCM QA is a dynamic department consisting of 60 competent people and 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 Contract Manufacturer Organisations worldwide. We focus on good social relations and well-being in the team and prioritise to make room for fun at work.
Contact
For further information, please contact Birgitte Madsen Find on +45 3075 4482.
Deadline
15 January 2023 Applications will be reviewed on-going. 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 5.9.2023, 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
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