QA Specialist for QC Projects
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Søborg
Are you keen on playing a crucial role in ensuring and overseeing Quality Control processes in our global network of Contract Manufacturer Organizations (CMOs)? Do you thrive in a job with lots of professional interfaces working with projects with many stakeholders? Then you could be our new colleague in Global Contract Manufacturing (GCM) Quality Assurance (QA) and we will look forward to welcoming you to our great team, read more and apply!
The position
In this position you will be QA responsible for the analytical method implemented at Novo Nordisk CMO’s. Your key task will be to ensure the quality of analysis and methods related to testing of outsourced raw materials, intermediates, drug substances, and drug products. You will participate in various projects working with both internal and external business partners and you must expect a high level of complexity and independent decision making in your daily tasks.
The job includes:
• QA review of analytical documentation from CMO’s such as protocols and reports for method validation
• Communication with CMO´s primarily via teleconferences
Keep up to date with changes in relevant guidelines and regulatory requirements
• Participate as needed in preparing GlobalLIMS (Laboratory Information Management System) for GMP materials, establishing and maintaining GlobalLIMS specifications and maintaining and approval of material masters in SAP Enterprise Core Component Since the manufacturers are located outside Denmark a few travel days per year might be expected. Qualifications
To succeed in this role, you:
• hold an academic degree as Pharmacist, Chemist, Engineer or similar
• have at least 2 years of experience with QC method validation in the pharma industry
• have a solid and up-to date knowledge of quality and GMP requirements
• are fluent in English and preferably have a good Danish proficiency too Experience in SAP and/or GlobalLIMS static will be seen as an advantage but is not required. On a personal level, you are an open-minded person with an outgoing attitude and natural networking skills. You take responsibility, work independently, and make decisions that balance quality demands, authority expectations and business needs. You meet your deadlines, and you know how to prioritize between different tasks in an everchanging environment. You have the ability to work in an international set-up with external stakeholders with different interests and agendas. Additionally, we would enjoy welcoming a straightforward person with a good sense of humor to our department. 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 45 competent people divided into 4 teams with focus on either operations, projects or QA Support. You will be a strong player in the QA Support team together with 2 other QA for QC professionals. 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 don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Associate Manager Marianne Hjulgaard on +45 30 79 86 31 or QA Senior Specialist Jette Johansen +45 30 75 44 83 Deadline
03 September 2023 We will review applications and perform interviews on an ongoing basis, so you are encouraged 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 your motivation in your resume or CV. To ensure an efficient and fair recruitment 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.
The position
In this position you will be QA responsible for the analytical method implemented at Novo Nordisk CMO’s. Your key task will be to ensure the quality of analysis and methods related to testing of outsourced raw materials, intermediates, drug substances, and drug products. You will participate in various projects working with both internal and external business partners and you must expect a high level of complexity and independent decision making in your daily tasks.
The job includes:
• QA review of analytical documentation from CMO’s such as protocols and reports for method validation
• Communication with CMO´s primarily via teleconferences
Keep up to date with changes in relevant guidelines and regulatory requirements
• Participate as needed in preparing GlobalLIMS (Laboratory Information Management System) for GMP materials, establishing and maintaining GlobalLIMS specifications and maintaining and approval of material masters in SAP Enterprise Core Component Since the manufacturers are located outside Denmark a few travel days per year might be expected. Qualifications
To succeed in this role, you:
• hold an academic degree as Pharmacist, Chemist, Engineer or similar
• have at least 2 years of experience with QC method validation in the pharma industry
• have a solid and up-to date knowledge of quality and GMP requirements
• are fluent in English and preferably have a good Danish proficiency too Experience in SAP and/or GlobalLIMS static will be seen as an advantage but is not required. On a personal level, you are an open-minded person with an outgoing attitude and natural networking skills. You take responsibility, work independently, and make decisions that balance quality demands, authority expectations and business needs. You meet your deadlines, and you know how to prioritize between different tasks in an everchanging environment. You have the ability to work in an international set-up with external stakeholders with different interests and agendas. Additionally, we would enjoy welcoming a straightforward person with a good sense of humor to our department. 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 45 competent people divided into 4 teams with focus on either operations, projects or QA Support. You will be a strong player in the QA Support team together with 2 other QA for QC professionals. 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 don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Associate Manager Marianne Hjulgaard on +45 30 79 86 31 or QA Senior Specialist Jette Johansen +45 30 75 44 83 Deadline
03 September 2023 We will review applications and perform interviews on an ongoing basis, so you are encouraged 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 your motivation in your resume or CV. To ensure an efficient and fair recruitment 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 Søborg.
Jobbet er oprettet på vores service den 22.3.2023, 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.
- Øvrige
- Søborg
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