QA specialist for Outsourcing
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Bagsværd
Are you seeking a dynamic and challenging role in an international environment? Are you a experienced professional or Specialist with expertise in GMP and especially aseptic manufacturing? Do you have passion for ensuring quality compliance in outsourced activities? Do you want to make a real impact on the lives of patients with diabetes and other chronic diseases? Our team is dedicated for providing a high level of QA support to the organization and making a difference for our patients and colleagues. 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.
We can offer a great working environment with high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. We ensure that there is a good work-life balance. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area.
The position
As a QA Specialist, you will play a pivotal role in the selection and assessment of CMOs, 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. In this role, you will:
Provide GMP direction to outsourced manufacturing and support the implementation of new quality compliance measures in close collaboration with management Facilitate critical cases (DV, CR, validation, etc.) in collaboration with line of Business (LoB) and GCM colleagues Drive internal compliance projects to ensure standards for outsourced activities Support CMOs in quality matters Participate in audits/inspections as coach and follow-up on QA findings Contribute to Process Groups, working groups, and projects related to QMS or your core area of expertise Serve as a subject matter expert in GMP and quality matters Deliver 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. Qualifications
As the ideal candidate you have previous experience within quality assurance, and you have worked with suppliers in a global environment. Pharmacist, Engineer or equivalent academic degree with minimum 6 years experience in a pharmaceutical organization Expertise in API and intermediates production, Tablet production, Aseptic formulation and filling production activities and/or Assembly & Packaging and related validation requirements. Up to date knowledge of pharmaceutical quality and GMP requirements for drug products, including audits, contract negotiation, validations, change control, NC handling, CAPA handling Expertise in quality requirement for contract manufactured products and experience with outsourcing will be an advantage Selfdriven and strong team player with excellent problem-solving and communication skills Proactive and solution-oriented with a can-do attitude and strategic focus 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.
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 3 other QA specialists and QA professionals working with master data. 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 Associate Manager Marianne Hjulgaard on +45 30 79 86 31 or QA Specialist Hans Juhl +45 30 79 54 12
Deadline
15th Marts 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.
We can offer a great working environment with high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. We ensure that there is a good work-life balance. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area.
The position
As a QA Specialist, you will play a pivotal role in the selection and assessment of CMOs, 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. In this role, you will:
As the ideal candidate you have previous experience within quality assurance, and you have worked with suppliers in a global environment.
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 3 other QA specialists and QA professionals working with master data. 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 Associate Manager Marianne Hjulgaard on +45 30 79 86 31 or QA Specialist Hans Juhl +45 30 79 54 12
Deadline
15th Marts 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 Bagsværd.
Jobbet er oprettet på vores service den 28.12.2022, 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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