Ambitious validation QA
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Måløv
Are you an experienced QA or Validation Professional with solid experience, who is eager to set direction and to ensure compliance, in close work with our stakeholders? Do you thrive in a constantly changing environment with various challenges and growth opportunities to handle? Do you believe in working together is better than working on your own?
Then you can be part of a team with responsibility for quality assurance for the equipment used within production and packaging of tablets in Oral Finished Product QA (OFP QA). You will influence and set directions in setting the right level of compliance, validation level and optimizing our ways of working by applying a LEAN mindset.
We offer a great working environment with high level of team spirit, as well as highly skilled, ambitious, and engaged colleagues who work together to find solutions and solve the tasks at hand. OFP QA consists of colleagues, based in both Måløv and Durham, US.
The job
You will be a part of the qualification team in OFP, where you will be working with qualification/validation of the equipment, the utilities, and the facilities for oral drug product manufacturing. You will act as a QA for the facility, equipment and the quality management system to ensure that the qualification documentation for implementation and maintenance of equipment complies with internal and external requirements. You will also contribute to finding solutions for ad hoc questions and challenges within compliance of cGMP.
Furthermore, you will be involved in the day-to-day business approving change requests, non-conformities, SOP’s, as well as trend reports for environmental monitoring and utilities needed for the operation of the plant. You will be present on shop floor and ensure continuous improvements in collaboration with our stakeholders and your colleagues across the department.
Our continuing high level of audit and inspection readiness is always on top of your agenda. Meaning that you work with QA oversight, where you proactively together with your colleagues and stakeholders, identify areas where our compliance can be strengthened.
Qualifications
We expect that you:
As we work in an international environment you must speak and write English fluently.
As an individual, you are open-minded, have a high-quality mind-set and works with high level of energy, an outgoing attitude and natural networking skills.
ou are a self-driven and independent person with a high sense of responsibility and initiative, who can prioritise many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with different stakeholders on various levels of the organization.
Additionally, we would enjoy welcoming to our department a straightforward person with a good sense of humour.
About the department
Oral Finished Products QA is a department with approximately 60 skilled and motivated colleagues. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development, as well the release of tablets for the market. We are proud to work in a fast-growing and ambitious part of Novo Nordisk.
Contact
For further information, please contact Birgitte Riis-Klausen, Associate Manager at +45 30795450.
Deadline
Deadline to apply for the position is November 27th, 2022.
Applications will be evaluated continuously, when received and candidates may be called for interview before the deadline.
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.
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Then you can be part of a team with responsibility for quality assurance for the equipment used within production and packaging of tablets in Oral Finished Product QA (OFP QA). You will influence and set directions in setting the right level of compliance, validation level and optimizing our ways of working by applying a LEAN mindset.
We offer a great working environment with high level of team spirit, as well as highly skilled, ambitious, and engaged colleagues who work together to find solutions and solve the tasks at hand. OFP QA consists of colleagues, based in both Måløv and Durham, US.
The job
You will be a part of the qualification team in OFP, where you will be working with qualification/validation of the equipment, the utilities, and the facilities for oral drug product manufacturing. You will act as a QA for the facility, equipment and the quality management system to ensure that the qualification documentation for implementation and maintenance of equipment complies with internal and external requirements. You will also contribute to finding solutions for ad hoc questions and challenges within compliance of cGMP.
Furthermore, you will be involved in the day-to-day business approving change requests, non-conformities, SOP’s, as well as trend reports for environmental monitoring and utilities needed for the operation of the plant. You will be present on shop floor and ensure continuous improvements in collaboration with our stakeholders and your colleagues across the department.
Our continuing high level of audit and inspection readiness is always on top of your agenda. Meaning that you work with QA oversight, where you proactively together with your colleagues and stakeholders, identify areas where our compliance can be strengthened.
Qualifications
We expect that you:
- Hold a Master’s degree in chemical engineering, pharmacy or other relevant MSc.
- Have minimum 3+ years of experience within the pharmaceutical industry and/or validation/qualification experience.
- Solve challenges and take the lead in optimising processes by applying LEAN Tools and principles.
- Have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity.
As we work in an international environment you must speak and write English fluently.
As an individual, you are open-minded, have a high-quality mind-set and works with high level of energy, an outgoing attitude and natural networking skills.
ou are a self-driven and independent person with a high sense of responsibility and initiative, who can prioritise many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with different stakeholders on various levels of the organization.
Additionally, we would enjoy welcoming to our department a straightforward person with a good sense of humour.
About the department
Oral Finished Products QA is a department with approximately 60 skilled and motivated colleagues. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development, as well the release of tablets for the market. We are proud to work in a fast-growing and ambitious part of Novo Nordisk.
Contact
For further information, please contact Birgitte Riis-Klausen, Associate Manager at +45 30795450.
Deadline
Deadline to apply for the position is November 27th, 2022.
Applications will be evaluated continuously, when received and candidates may be called for interview before the deadline.
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.
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 8.11.2022, 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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