QA Aseptic Specialist
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Søborg
Are you seeking a dynamic role in an international environment? Are you an experienced professional or Specialist with expertise in GMP and especially aseptic manufacturing? Do you have passion for ensuring quality compliance in outsourced activities? Then read more and apply to become our new QA Specialist!
The position
As a QA Specialist, you will play a pivotal role in the selection and assessment of Contract Manufacturing Organizations (CMOs), negotiation and implementation of Quality Agreements, and support of outsourced production activities. You will serve as a subject matter expert with your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
In this role, you will:
• Provide GMP direction to outsourced manufacturing
• Support the implementation of new quality compliance measures in close collaboration with management
• Facilitate critical cases in collaboration with line of Business and Global Contract Manufacturing (GCM) colleagues
• Drive internal compliance projects to ensure standards for outsourced activities
• Participate in audits/inspections as coach and follow-up on QA findings
Moreover, you will contribute to Process Groups, working groups, and projects related to Quality Management System, or your core area of expertise and you will be delivering training in quality activities.
The role requires up to 20-30 days of travel per year to primarily CMO 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.
You will find that you have rich opportunities to create great results and develop yourself, both on a professional and on a personal level. We implement individual development plans which support your growth and assist you in achieving your professional ambitions.
Qualifications
As the ideal candidate you have previous experience within quality assurance, and you have worked with suppliers in a global environment. You have up to date knowledge of pharmaceutical quality and GMP requirements for drug products, including audits, contract negotiation, validations, change control, Non-Conformities handling, Corrective Actions and Preventive Actions handling.
To succeed in this role, you:
• Hold a Master’s degree in Pharmacy, Engineering or similar
• Have minimum 6 years’ experience in a pharmaceutical organization
• Have expertise in aseptic formulation and filling production activities
• Are fluent in English both written and spoken
Expertise in quality requirement for contract manufactured products and experience with outsourcing will be seen as an advantage.
On a personal level, you are self-driven, a strong team player with excellent problem-solving and communication skills and you are proactive and solution-oriented with a can-do attitude and strategic focus. Finally, you are recognised as a skilled communicator who can engage at all levels of the organization and make independent decisions. About the department
GCM QA is responsible for quality assurance and quality support to outsourced production activities worldwide. We are 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 4 other QA specialists. The department is characterised by a high level of professionalism, flexibility, and cooperation.
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 and good work-life balance. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area.
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 Specialist Rasmus Krogh-Madelung +45 30 75 60 71 Deadline
23 April 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 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.
The position
As a QA Specialist, you will play a pivotal role in the selection and assessment of Contract Manufacturing Organizations (CMOs), negotiation and implementation of Quality Agreements, and support of outsourced production activities. You will serve as a subject matter expert with your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
In this role, you will:
• Provide GMP direction to outsourced manufacturing
• Support the implementation of new quality compliance measures in close collaboration with management
• Facilitate critical cases in collaboration with line of Business and Global Contract Manufacturing (GCM) colleagues
• Drive internal compliance projects to ensure standards for outsourced activities
• Participate in audits/inspections as coach and follow-up on QA findings
Moreover, you will contribute to Process Groups, working groups, and projects related to Quality Management System, or your core area of expertise and you will be delivering training in quality activities.
The role requires up to 20-30 days of travel per year to primarily CMO 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.
You will find that you have rich opportunities to create great results and develop yourself, both on a professional and on a personal level. We implement individual development plans which support your growth and assist you in achieving your professional ambitions.
Qualifications
As the ideal candidate you have previous experience within quality assurance, and you have worked with suppliers in a global environment. You have up to date knowledge of pharmaceutical quality and GMP requirements for drug products, including audits, contract negotiation, validations, change control, Non-Conformities handling, Corrective Actions and Preventive Actions handling.
To succeed in this role, you:
• Hold a Master’s degree in Pharmacy, Engineering or similar
• Have minimum 6 years’ experience in a pharmaceutical organization
• Have expertise in aseptic formulation and filling production activities
• Are fluent in English both written and spoken
Expertise in quality requirement for contract manufactured products and experience with outsourcing will be seen as an advantage.
On a personal level, you are self-driven, a strong team player with excellent problem-solving and communication skills and you are proactive and solution-oriented with a can-do attitude and strategic focus. Finally, you are recognised as a skilled communicator who can engage at all levels of the organization and make independent decisions. About the department
GCM QA is responsible for quality assurance and quality support to outsourced production activities worldwide. We are 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 4 other QA specialists. The department is characterised by a high level of professionalism, flexibility, and cooperation.
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 and good work-life balance. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area.
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 Specialist Rasmus Krogh-Madelung +45 30 75 60 71 Deadline
23 April 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 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 29.3.2023, 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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