Dedicated IT Validation responsible to production in Oral Finished Products

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Are you passionate about systems and IT within production? Do you want to be a part of a bigger cause and help people with diabetes across the world? Then this might be the right opportunity for you. We are looking for an IT System Manager to Oral Finished Products (OFP) to become part of a game changing tablet production for diabetes treatment.

About the department

You will be part of the IT & Automation team in the Technical Support department, which is responsible for maintenance & support of IT, facilities, utilities, equipment, and other support related functions. The IT & Automation team’s responsibilities are to initiate, drive, and participate in various IT related tasks with the purpose of ensuring our production, compliance and future quality and regulatory requirements, and driving the digitalisation strategy for Oral Finished products. You will be in a team, where there is a great atmosphere and team spirit. We are a group of people with various backgrounds, but we all have in common to support and help each other, have a good time and to make a big difference.

The position

In Oral Finished Products we work together with one common goal; to deliver our products to the patients that needs it, so that we can do a life-changing difference. In this position you will contribute to this by making sure, that our production systems support the tablet production in the best possible way. Our MES (manufacturing Execution System) is called PAS-X, and in Technical Support we have the responsibility to make sure, that it is working as expected. It is our responsibility to implement changes to PAS-X in accordance with requirements from our production and health authorities. For this we need a IT Validation responsible who will manage our validation approach and ensure that test protocols, change request, validation plans and SOP’s are in compliance with the overall validation concepts of Novo Nordisk and in our area, OFP.


Your day-day work consists of coordinating activities with our stakeholders in the production and together clarify which solutions will be possible to do within the system and according to the current regulatory requirements.

Qualifications

The ideal candidate has an Engineering, Pharmaceutical, Science or IT master’s degree and preferable 2-5 years of experience with validation, production, process optimisation, and/or IT. The experience can come from fulltime, student jobs, and/or internships. It is an advantage if your validation experience has been in relation to MES systems in a pharma regulated environment, but not a requirement

You thrive in a dynamic environment where the priorities often change and where you do not compromise on the quality of your work and the documentation within your scope. You are a team player that enjoys a lot of social interaction.

Oral Finish Products

In 2004 Novo Nordisk initiated the ambitious and pioneering work of being the first company to offer a GLP-1 based oral alternative, to type2 diabetes patients all over the world. In 2019 we got the first approval to send our GLP-1 based tablet to the market, and we are already represented in US, EU, and other parts of the world. The pioneer spirit is what characterises Oral Finished Products. Every day we apply our very best efforts in optimising and developing our production, to be able to help even more patients all over the world. To succeed with this, we need you! So, get on board, our fantastic journey has just begun.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


Dedicated IT Validation responsible to production in Oral Finished Products

Are you passionate about systems and IT within production? Do you want to be a part of a bigger cause and help people with diabetes across the world? Then this might be the right opportunity for you. We are looking for an IT System Manager to Oral Finished Products (OFP) to become part of a game changing tablet production for diabetes treatment.

About the department

You will be part of the IT & Automation team in the Technical Support department, which is responsible for maintenance & support of IT, facilities, utilities, equipment, and other support related functions. The IT & Automation team’s responsibilities are to initiate, drive, and participate in various IT related tasks with the purpose of ensuring our production, compliance and future quality and regulatory requirements, and driving the digitalisation strategy for Oral Finished products. You will be in a team, where there is a great atmosphere and team spirit. We are a group of people with various backgrounds, but we all have in common to support and help each other, have a good time and to make a big difference.

The position

In Oral Finished Products we work together with one common goal; to deliver our products to the patients that needs it, so that we can do a life-changing difference. In this position you will contribute to this by making sure, that our production systems support the tablet production in the best possible way. Our MES (manufacturing Execution System) is called PAS-X, and in Technical Support we have the responsibility to make sure, that it is working as expected. It is our responsibility to implement changes to PAS-X in accordance with requirements from our production and health authorities. For this we need a IT Validation responsible who will manage our validation approach and ensure that test protocols, change request, validation plans and SOP’s are in compliance with the overall validation concepts of Novo Nordisk and in our area, OFP.


Your day-day work consists of coordinating activities with our stakeholders in the production and together clarify which solutions will be possible to do within the system and according to the current regulatory requirements.

Qualifications

The ideal candidate has an Engineering, Pharmaceutical, Science or IT master’s degree and preferable 2-5 years of experience with validation, production, process optimisation, and/or IT. The experience can come from fulltime, student jobs, and/or internships. It is an advantage if your validation experience has been in relation to MES systems in a pharma regulated environment, but not a requirement

You thrive in a dynamic environment where the priorities often change and where you do not compromise on the quality of your work and the documentation within your scope. You are a team player that enjoys a lot of social interaction.

Oral Finish Products

In 2004 Novo Nordisk initiated the ambitious and pioneering work of being the first company to offer a GLP-1 based oral alternative, to type2 diabetes patients all over the world. In 2019 we got the first approval to send our GLP-1 based tablet to the market, and we are already represented in US, EU, and other parts of the world. The pioneer spirit is what characterises Oral Finished Products. Every day we apply our very best efforts in optimising and developing our production, to be able to help even more patients all over the world. To succeed with this, we need you! So, get on board, our fantastic journey has just begun.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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