Senior QA Profesional- Emerging Technologies
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Are you passionate about setting direction within emerging technologies and ensuring compliance? Do you have experience within Quality Control? Are you skilled in navigating complex stakeholder landscapes and motivating teams to deliver great results? Do you thrive in a constantly changing environment with various challenges and growth opportunities to handle? If so, we have an exciting opportunity for you. The Position
In close cooperation with your colleagues, you act as a QA for QC servicing our QC laboratories. You contribute to finding solutions for ad hoc questions and challenges within compliance of QC laboratories. You have a risk-based approach to the quality control process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.
Key responsibilities include:
• Approving the documentation needed for the operation of the laboratories such as change requests, deviations, and SOP’s.
• Assisting your colleagues in ensuring the qualification of laboratory equipment and validation of methods for analyzing drug products for the market is compliant with internal and external requirements.
• Ensuring our continuing high level of audit and inspection readiness, with a focus on QA oversight, which entails proactively working with your colleagues to identify areas where our compliance can be strengthened.
Qualifications
To succeed in this role, you have:
• Master’s degree as pharmacist, engineer or similar.
• Around +5 years of experience from a pharmaceutical or medical device organization, where you have gained a solid and up-to-date knowledge of quality and GMP requirements.
• Thorough knowledge within analysis validation, analysis equipment qualification, project management, as well as laboratory computer system validation. CMO (contract manufacturing operations) is a plus.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment while challenging the status quo.
• Fluency in both English and Danish.
The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You are a self-motivated and independent person with a high level of responsibility and initiative who can prioritize your various tasks.
You enjoy working in a dynamic environment, where teamwork is essential, and you like collaborating with many different stakeholders – internally and externally.
At , your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
About the department
Emerging Technologies QA is a new area within Novo Nordisk, we employ approximately 100 employees and we are still growing. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development as well the release of tablets and future emerging technologies products for the market. You will become part of a great QA department (Emerging Technologies QA New Entry & Support), with many interfaces around the organization. The department consists of around 30 people divided into four teams. This position is in the QA for Quality Control team, that consists of 6 highly knowledgeable and skilled people, covering the diverse area of Quality Control. In the department, we embrace challenges as opportunities. We have a vibrant and positive working environment, good values and exchange of knowledge and experience. We all work towards continuously improving our competences, as well as making work processes more efficient and effective. Working at We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at , life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Semra Nur Canbaz (Manager) at +.
Deadline
16 June 2024 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 CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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.
In close cooperation with your colleagues, you act as a QA for QC servicing our QC laboratories. You contribute to finding solutions for ad hoc questions and challenges within compliance of QC laboratories. You have a risk-based approach to the quality control process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.
Key responsibilities include:
• Approving the documentation needed for the operation of the laboratories such as change requests, deviations, and SOP’s.
• Assisting your colleagues in ensuring the qualification of laboratory equipment and validation of methods for analyzing drug products for the market is compliant with internal and external requirements.
• Ensuring our continuing high level of audit and inspection readiness, with a focus on QA oversight, which entails proactively working with your colleagues to identify areas where our compliance can be strengthened.
Qualifications
To succeed in this role, you have:
• Master’s degree as pharmacist, engineer or similar.
• Around +5 years of experience from a pharmaceutical or medical device organization, where you have gained a solid and up-to-date knowledge of quality and GMP requirements.
• Thorough knowledge within analysis validation, analysis equipment qualification, project management, as well as laboratory computer system validation. CMO (contract manufacturing operations) is a plus.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment while challenging the status quo.
• Fluency in both English and Danish.
The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You are a self-motivated and independent person with a high level of responsibility and initiative who can prioritize your various tasks.
You enjoy working in a dynamic environment, where teamwork is essential, and you like collaborating with many different stakeholders – internally and externally.
At , your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
About the department
Emerging Technologies QA is a new area within Novo Nordisk, we employ approximately 100 employees and we are still growing. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development as well the release of tablets and future emerging technologies products for the market. You will become part of a great QA department (Emerging Technologies QA New Entry & Support), with many interfaces around the organization. The department consists of around 30 people divided into four teams. This position is in the QA for Quality Control team, that consists of 6 highly knowledgeable and skilled people, covering the diverse area of Quality Control. In the department, we embrace challenges as opportunities. We have a vibrant and positive working environment, good values and exchange of knowledge and experience. We all work towards continuously improving our competences, as well as making work processes more efficient and effective. Working at We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at , life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Semra Nur Canbaz (Manager) at +.
Deadline
16 June 2024 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 CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At 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 Måløv.
Jobbet er oprettet på vores service den 30.4.2024, 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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