Senior QA Specialist for Aseptic Production
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Søborg
Are you ready to be a key player in the global landscape of Contract Manufacturing Organizations (CMOs)? Can you see yourself leveraging your extensive QA and GMP knowledge to ensure product quality, drive compliance, and facilitate critical cases in collaboration with cross-functional teams? Then read more and apply to join us! The position
As a Senior QS Specialist in Global Contract Manufacturing (GCM) QA you will play a pivotal role in the selection and assessment of CMOs, due diligence related to acquisitions, negotiation and implementation of Quality Agreements, and support of outsourced production activities. Your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
Your main responsibilities will be to:
• Provide GMP direction to outsourced manufacturing and support the implementation of new quality compliance measures in close collaboration with management
• Facilitate critical cases in collaboration with line of Business and GCM QA colleagues
• Monitor validation requirement within Aseptic production, including process media fills, equipment and cleaning validation
• Participate in compliance discussions with QA Manager, CVP and CMO QA management.
• Drive internal compliance projects to ensure standards for outsourced activities
This is also a unique opportunity to be part of selection process including assessment of potential new CMO’s and participate in due diligence of potential new assets and companies and afterward integration.
Furthermore, you will contribute to Process Groups, working groups, and projects related to QMS or your core area of expertise, serving as a subject matter expert in GMP and quality matters and by delivering training in quality activities.
The role requires up to 20-30 days of travel per year to primarily CMOs locations outside of Denmark. If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you. Qualifications
We are looking for a specialist understanding of the complexity of the interlinked different areas within the aseptic processes.
To succeed in this role, you:
• Hold a master’s degree in pharmacy, Chemistry, Engineering or similar
• Have a proven track record of significant experience within aseptic production in the pharmaceutical industry
• Preferably have QA or GMP auditing experience
• Are fully proficient in English
If you are a Qualified Person and have experience with suppliers in a global environment and technology transfer from development to commercial phase and/or as part of products from one site to another it will be seen as an advantage, as well as expertise in quality requirement for contract manufactured products and outsourcing.
On a personal level, you are a self-driven and strong team player with excellent problem-solving and communication skills; you are proactive and solution-oriented with a can-do attitude and strategic focus. Finally, your excellent communication skills allow you to engage at all levels of the organization and make independent decisions.
About the department
GCM QA – Drug Product (- DP) is responsible for product quality and QA Oversight of CMOs and the final batch release of batches produced externally.
At the moment the department consists of 30 highly qualified employees in 4 different teams, but we are growing very fast and expecting to become bigger in the nearest future.
You will be a strong player in the QA Support team together with 8 other team members. The department is characterised by a high level of professionalism, flexibility, and cooperation.
We can offer a great working environment with high level of team spirit as well as a highly skilled team of ambitious and engaged colleagues. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area. We focus on good social relations and prioritise to make room for fun at work.
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 44 83 or QA Senior Specialist +45 30 79 36 00 Deadline
7 January 2024
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.
As a Senior QS Specialist in Global Contract Manufacturing (GCM) QA you will play a pivotal role in the selection and assessment of CMOs, due diligence related to acquisitions, negotiation and implementation of Quality Agreements, and support of outsourced production activities. Your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
Your main responsibilities will be to:
• Provide GMP direction to outsourced manufacturing and support the implementation of new quality compliance measures in close collaboration with management
• Facilitate critical cases in collaboration with line of Business and GCM QA colleagues
• Monitor validation requirement within Aseptic production, including process media fills, equipment and cleaning validation
• Participate in compliance discussions with QA Manager, CVP and CMO QA management.
• Drive internal compliance projects to ensure standards for outsourced activities
This is also a unique opportunity to be part of selection process including assessment of potential new CMO’s and participate in due diligence of potential new assets and companies and afterward integration.
Furthermore, you will contribute to Process Groups, working groups, and projects related to QMS or your core area of expertise, serving as a subject matter expert in GMP and quality matters and by delivering training in quality activities.
The role requires up to 20-30 days of travel per year to primarily CMOs locations outside of Denmark. If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you. Qualifications
We are looking for a specialist understanding of the complexity of the interlinked different areas within the aseptic processes.
To succeed in this role, you:
• Hold a master’s degree in pharmacy, Chemistry, Engineering or similar
• Have a proven track record of significant experience within aseptic production in the pharmaceutical industry
• Preferably have QA or GMP auditing experience
• Are fully proficient in English
If you are a Qualified Person and have experience with suppliers in a global environment and technology transfer from development to commercial phase and/or as part of products from one site to another it will be seen as an advantage, as well as expertise in quality requirement for contract manufactured products and outsourcing.
On a personal level, you are a self-driven and strong team player with excellent problem-solving and communication skills; you are proactive and solution-oriented with a can-do attitude and strategic focus. Finally, your excellent communication skills allow you to engage at all levels of the organization and make independent decisions.
About the department
GCM QA – Drug Product (- DP) is responsible for product quality and QA Oversight of CMOs and the final batch release of batches produced externally.
At the moment the department consists of 30 highly qualified employees in 4 different teams, but we are growing very fast and expecting to become bigger in the nearest future.
You will be a strong player in the QA Support team together with 8 other team members. The department is characterised by a high level of professionalism, flexibility, and cooperation.
We can offer a great working environment with high level of team spirit as well as a highly skilled team of ambitious and engaged colleagues. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area. We focus on good social relations and prioritise to make room for fun at work.
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 44 83 or QA Senior Specialist +45 30 79 36 00 Deadline
7 January 2024
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 Søborg.
Jobbet er oprettet på vores service den 7.12.2023, 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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