IT Validation Lead
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Måløv
Are you ready for a unique opportunity to shape the validation direction for Laboratories of the Future in Novo Nordisk? Do you have a quality mindset and are you eager to contribute your energy and talent in a in a highly engaged team? Then join us as an IT Validation Lead in Analytical IT, CMC.
The position
You will be part of a team that works to implement, validate, and support Laboratory IT Solutions. We have a natural desire to always look for smarter ways of doing things and are always working to contribute to improving Novo Nordisk’s standards and services. A key part of the position will be to be involved in a large automation project (+50mdkk investment) building the IT infrastructure for laboratories of the future in Novo Nordisk. The objective is to create fully automated Quality Control (QC) work-cells / lines in R&ED and subsequently scale the to the rest of the company.
Your daily tasks and responsibilities will be to:
• Lead and participate in projects as responsible for the end-to-end direction and quality with respect to IT & Validation
• Work collaboratively across functions with Quality Assurance, IT, Line of Business, and vendors to plan, coordinate and execute computer system validation activities
• Perform risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes
• Drive IT projects and participate and large automation/digitalisation groups
• Have the ownership for the development and delivery of complete validation packages, incl. IT Risk Assessment
• Facilitate verification and validation activities including test execution, documentation review and approval
• Seeking new ways of working by simplifying and improving the processes
Qualifications
We expect you to have:
• A relevant academic background and at least 5 years of relevant experience with GMP/IT/validation.
• You have experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in your profession. Also experience or interest within Azure DevOps, TIMS3 (HP Quality center), software development and scripted/automated testing is meriting.
• Experience working with the guidelines provided by the global regulatory agencies and authority agencies such as FDA and MHRA in areas such as GxP, USP1058, FDA 21CFR part 11, GAMP Annex11, MHRA ‘GXP’ Data Integrity Guidance and Definitions, PIC/S or corporate interpretations hereof Agile software development
• Good knowledge about GAMP framework
• Solid project management skills
• Excellent communication skills in Danish and English
As a person you are:
• Team-oriented person
• Self-driven, proactive, and responsible
• Willing to bring your thoughts out in the open, creating a healthy discussion, and at the same time, setting a direction
• Able to operate with frequent changes
• Willing to give and receive feedback
• Willing to challenge the business processes
• Willing to collaborate close with stakeholders
About the department
The department QC Technology & IT is part of the Novo Nordisk Research & Early Development (R&ED) family, developing novel analysis for drug candidates in clinical trials all over the world. You will be able to use your skills and talent not only in our department, but across the entire Drug Product Development field.
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.
Contact
For further information, please contact Manager, Hamza Bakir at +45 3075 3033
Deadline
11th of December 2022.
Applications will be reviewed continuously, and we will begin conducting interviews already during the posting period, so please do not hesitate to apply.
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
The position
You will be part of a team that works to implement, validate, and support Laboratory IT Solutions. We have a natural desire to always look for smarter ways of doing things and are always working to contribute to improving Novo Nordisk’s standards and services. A key part of the position will be to be involved in a large automation project (+50mdkk investment) building the IT infrastructure for laboratories of the future in Novo Nordisk. The objective is to create fully automated Quality Control (QC) work-cells / lines in R&ED and subsequently scale the to the rest of the company.
Your daily tasks and responsibilities will be to:
• Lead and participate in projects as responsible for the end-to-end direction and quality with respect to IT & Validation
• Work collaboratively across functions with Quality Assurance, IT, Line of Business, and vendors to plan, coordinate and execute computer system validation activities
• Perform risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes
• Drive IT projects and participate and large automation/digitalisation groups
• Have the ownership for the development and delivery of complete validation packages, incl. IT Risk Assessment
• Facilitate verification and validation activities including test execution, documentation review and approval
• Seeking new ways of working by simplifying and improving the processes
Qualifications
We expect you to have:
• A relevant academic background and at least 5 years of relevant experience with GMP/IT/validation.
• You have experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in your profession. Also experience or interest within Azure DevOps, TIMS3 (HP Quality center), software development and scripted/automated testing is meriting.
• Experience working with the guidelines provided by the global regulatory agencies and authority agencies such as FDA and MHRA in areas such as GxP, USP1058, FDA 21CFR part 11, GAMP Annex11, MHRA ‘GXP’ Data Integrity Guidance and Definitions, PIC/S or corporate interpretations hereof Agile software development
• Good knowledge about GAMP framework
• Solid project management skills
• Excellent communication skills in Danish and English
As a person you are:
• Team-oriented person
• Self-driven, proactive, and responsible
• Willing to bring your thoughts out in the open, creating a healthy discussion, and at the same time, setting a direction
• Able to operate with frequent changes
• Willing to give and receive feedback
• Willing to challenge the business processes
• Willing to collaborate close with stakeholders
About the department
The department QC Technology & IT is part of the Novo Nordisk Research & Early Development (R&ED) family, developing novel analysis for drug candidates in clinical trials all over the world. You will be able to use your skills and talent not only in our department, but across the entire Drug Product Development field.
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.
Contact
For further information, please contact Manager, Hamza Bakir at +45 3075 3033
Deadline
11th of December 2022.
Applications will be reviewed continuously, and we will begin conducting interviews already during the posting period, so please do not hesitate to apply.
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 22.11.2022, 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
Lignende jobs
-
Senior Associates og Managers til Transaction Advi...
Fri kontaktSenior Associates og Managere til Transaction Advisory Service i København. Vi mærker en stigende efterspørgsel efter rådgivning i forbindelse med køb og salg af virksomheder, herunder finansiel due diligence. Derfor søger vi Senior Associates og Managere til vores TAS team på Østerbro.Få mere info- Øvrige
- København Ø
-
Breakfast Manager, fuldtid, Scandic Webers
Fri kontaktEr du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Breakfast Manager på Scandic Webers. Vi ved, at du ta’r ansvar og har ro i maven med det fulde overblik. Du er god til at organisere, købe ind, lede og dele din viden.Få mere info- Øvrige
- København
-
Erfaren konsulent med politisk tæft til SMV & Ivær...
Fri kontaktLeder du efter et sted, hvor du kan få en vigtig rolle med politikudvikling, kommunikation og politisk interessevaretagelse inden for erhvervspolitik? Så har vi jobbet her i teamet for ’SMV & Iværksætteri’. SMV’er og iværksættere udgør rygraden af dansk erhvervsliv. Deres succes er Danmarks succes.Få mere info- Øvrige
- København V
Statistik over udbudte jobs som øvrige i Måløv
Herunder ser du udviklingen i udbudte øvrige i Måløv over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.
Se flere statistikker her:
Statistik over udbudte øvrige i Måløv over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 22. november 2024 | 5 |
| 21. november 2024 | 5 |
| 20. november 2024 | 5 |
| 19. november 2024 | 5 |
| 18. november 2024 | 5 |
| 17. november 2024 | 10 |
| 16. november 2024 | 10 |
| 15. november 2024 | 11 |
| 14. november 2024 | 12 |
| 13. november 2024 | 12 |
| 12. november 2024 | 11 |
| 11. november 2024 | 9 |
| 10. november 2024 | 11 |
| 9. november 2024 | 11 |
| 8. november 2024 | 11 |
| 7. november 2024 | 10 |
| 6. november 2024 | 11 |
| 5. november 2024 | 11 |
| 4. november 2024 | 9 |
| 3. november 2024 | 10 |
| 2. november 2024 | 10 |
| 1. november 2024 | 11 |
| 31. oktober 2024 | 11 |
| 30. oktober 2024 | 11 |
| 29. oktober 2024 | 11 |
| 28. oktober 2024 | 11 |
| 27. oktober 2024 | 13 |
| 26. oktober 2024 | 13 |
| 25. oktober 2024 | 13 |
| 24. oktober 2024 | 13 |
| 23. oktober 2024 | 11 |