IT Compliance Responsible
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Gentofte
Do you have experience with IT systems used for pharmaceutical or regulated production purposes? Do you have a strong quality mindset, a hands-on attitude, and a wish to provide support and guidance across a broad stakeholder landscape? We hope so! Then you could be our new IT Compliance Responsible within Manufacturing IT's Biotech & Rare Disease area in Novo Nordisk (MIT BRD).
Apply and join us today What is the role about
In today's world, change is the one thing we can count on. But whatever the future brings, our patients remain at the heart of everything we do. That's where you come in, working with dedicated colleagues in an exciting, fast-paced environment.
Your responsibility will cover the following: Help govern our IT license to operate in relation to GxP IT systems and support Associate Managers, System Owners, and IT/OT teams across BRD Partake in IT projects and be part of defining and implementing best practices around system management Help implement changing or new requirements related to IT compliance in BRD Act as a liaison partner for Associate Managers, System Owners, and IT/OT teams Work hands-on to ensure that our systems are following relevant IT compliance requirements and that needed documentation is authored and in place Prepare for approval of validation documentation together with Novo Nordisk Quality Assurance
Moreover, you will also ensure all relevant periodic activities are completed timely and in good quality - such as IT risk assessments, LCM assessments, periodic IT system evaluations, user review reporting, and other needed reporting. Furthermore, you will provide escalation support when needed and coordinate between relevant parties.
What we are looking for
A vital skill required for this job is experiences with IT systems used for pharmaceutical or regulated production purposes. Furthermore, experience with IT Projects, ISO-documented processes, GMP understanding, and knowledge of GAMP5. Preferably, you hold a BSc or MSc degree in Computer Science, Business Administration, Engineering, or similar backed by 5+ years of relevant experience within governance, operation, and maintenance of IT systems Candidates with non-academic backgrounds and vast experience within the relevant fields will also be considered Good written and spoken proficiency in Danish and English
As a person, you are structured, a team player, and a good communicator, and you can drive your tasks to completion. You also have a strong analytical and quality mindset and are known for building good relations with your colleagues and stakeholders at all organizational levels. The department waiting for you
You will join a team with very committed colleagues, we are organisational placed in Manufacturing IT operating to support BRD API production where we partner with production. Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, a global production network at the forefront of technology and quality pharmaceutical products. In BRD, we are supplying all Novo Nordisk products for Rare Diseases and using our competencies in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. Manufacturing IT is anchored in Digital, Data & IT and is the Novo Nordisk Product Supply partner. Working at Novo Nordisk
Novo Nordisk is a global healthcare company headquartered in Denmark. For almost 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that. We are proud of our people too, and we employ more than 50,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change people's lives worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in Novo Nordisk. Contact
For further information, please contact Mehmet Cinar on +45 30 75 76 78. Deadline Please apply before the 21st of May 2023. We are screening candidates and conduct interviews on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying for this position in your resume in the 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.
Apply and join us today What is the role about
In today's world, change is the one thing we can count on. But whatever the future brings, our patients remain at the heart of everything we do. That's where you come in, working with dedicated colleagues in an exciting, fast-paced environment.
Your responsibility will cover the following:
Moreover, you will also ensure all relevant periodic activities are completed timely and in good quality - such as IT risk assessments, LCM assessments, periodic IT system evaluations, user review reporting, and other needed reporting. Furthermore, you will provide escalation support when needed and coordinate between relevant parties.
What we are looking for
A vital skill required for this job is experiences with IT systems used for pharmaceutical or regulated production purposes. Furthermore, experience with IT Projects, ISO-documented processes, GMP understanding, and knowledge of GAMP5.
As a person, you are structured, a team player, and a good communicator, and you can drive your tasks to completion. You also have a strong analytical and quality mindset and are known for building good relations with your colleagues and stakeholders at all organizational levels. The department waiting for you
You will join a team with very committed colleagues, we are organisational placed in Manufacturing IT operating to support BRD API production where we partner with production. Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, a global production network at the forefront of technology and quality pharmaceutical products. In BRD, we are supplying all Novo Nordisk products for Rare Diseases and using our competencies in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. Manufacturing IT is anchored in Digital, Data & IT and is the Novo Nordisk Product Supply partner. Working at Novo Nordisk
Novo Nordisk is a global healthcare company headquartered in Denmark. For almost 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that. We are proud of our people too, and we employ more than 50,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change people's lives worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in Novo Nordisk. Contact
For further information, please contact Mehmet Cinar on +45 30 75 76 78. Deadline Please apply before the 21st of May 2023. We are screening candidates and conduct interviews on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying for this position in your resume in the 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 Gentofte.
Jobbet er oprettet på vores service den 28.4.2023, 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.
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