QA Professional
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Måløv
Are you up for a role where you will be ensuring compliance and high quality in all parenteral development drug products used in clinical trials? Are you driven by a passion of contributing to secure patient safety? Are you looking to work in an inclusive team where you can bring your whole self to work? If so, we have an exciting opportunity waiting for you as our new colleague in CMC PPF QA!
The position
As our new QA Professional, you will be working in CMC Parenteral Protein Formulation QA (PPF QA) in Måløv with occasional assignments in greater Copenhagen area as well. Furthermore, travel days can be expected when working with our international Contract Manufacturing Organisations (CMO) where we are producing clinical batches as well. You will support our aseptic pilot plant and their activities for all Novo Nordisk parenteral development projects and ensure compliance to cGMP requirements. You will support the departments and facilities working with development and manufacturing of parenteral drug products.
In your daily work you will review and approve documents in connection with development, manufacture, stability and status assignment of clinical batches produced in CMC and Product Supply. In collaboration with colleagues and stakeholders, you will also identify and contribute to strengthening the compliance level in our production facility. Approval of deviations and change request as well as batch review will, also be a significant part of your job.
Qualifications
You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production, and hence you know how to manoeuvre without adding unnecessary complexity. You have a pragmatic approach to problem-solving and a strong quality mindset.
We imagine the ideal candidate has:
We also welcome applications if you are a new talent who graduated recently or are in the beginning of your career if you share our passion for quality, GMP and problem-solving, and are keen to acquire professional competencies to become what we describe as an “ideal candidate”. Also, if you are in the fall of your professional career and would enjoy requiring new competencies you are also welcomed to apply.
On a personal level, you are straightforward, eager to see things moving in a dynamic environment where projects and processes vary, requiring flexibility and skills to organise and drive tasks. You are self-driven and independent with a high sense of responsibility and initiative, and you know how to prioritise your many different tasks. You are a team player with great interpersonal skills because teamwork and collaboration are on the top of our agenda.
About the department
You will become part of a department consisting of three teams where we currently are more than 20 dedicated colleagues and several open positions as we are expanding. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, in order to ensure Novo Nordisk’s critical delivery of medicines to patients.
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 Marianne Mørch Hansen +45 3079 8154.
Deadline
20th of November. Applications will be screened 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 why you are applying 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.
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.
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The position
As our new QA Professional, you will be working in CMC Parenteral Protein Formulation QA (PPF QA) in Måløv with occasional assignments in greater Copenhagen area as well. Furthermore, travel days can be expected when working with our international Contract Manufacturing Organisations (CMO) where we are producing clinical batches as well. You will support our aseptic pilot plant and their activities for all Novo Nordisk parenteral development projects and ensure compliance to cGMP requirements. You will support the departments and facilities working with development and manufacturing of parenteral drug products.
In your daily work you will review and approve documents in connection with development, manufacture, stability and status assignment of clinical batches produced in CMC and Product Supply. In collaboration with colleagues and stakeholders, you will also identify and contribute to strengthening the compliance level in our production facility. Approval of deviations and change request as well as batch review will, also be a significant part of your job.
Qualifications
You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production, and hence you know how to manoeuvre without adding unnecessary complexity. You have a pragmatic approach to problem-solving and a strong quality mindset.
We imagine the ideal candidate has:
- An academic degree as a pharmacist, engineer, or similar.
- Approx. three years’ experience from a pharmaceutical company, preferable within quality assurance or in aseptic production.
- Solid and up-to date knowledge of quality and Good Manufacturing Processes (GMP) requirements.
- Profound understanding of regulations, requirements and guidelines in pharmaceutical development.
- Strong communication skills and ability to translate complex content.
- Fluent in Danish and English.
We also welcome applications if you are a new talent who graduated recently or are in the beginning of your career if you share our passion for quality, GMP and problem-solving, and are keen to acquire professional competencies to become what we describe as an “ideal candidate”. Also, if you are in the fall of your professional career and would enjoy requiring new competencies you are also welcomed to apply.
On a personal level, you are straightforward, eager to see things moving in a dynamic environment where projects and processes vary, requiring flexibility and skills to organise and drive tasks. You are self-driven and independent with a high sense of responsibility and initiative, and you know how to prioritise your many different tasks. You are a team player with great interpersonal skills because teamwork and collaboration are on the top of our agenda.
About the department
You will become part of a department consisting of three teams where we currently are more than 20 dedicated colleagues and several open positions as we are expanding. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, in order to ensure Novo Nordisk’s critical delivery of medicines to patients.
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 Marianne Mørch Hansen +45 3079 8154.
Deadline
20th of November. Applications will be screened 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 why you are applying 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.
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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 6.7.2022, 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.
- Øvrige
- Måløv
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