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Quality Professional / Delegated QP

Summary

Are you an experienced Quality Professional with a positive and pragmatic attitude? Then you might be the person we are looking for!We are currently looking for a new Quality Professional/Delegated QP to join our External Quality Operations based in Hillerød, Denmark.

Job Category: Quality

Requisition Number: 37488BR

Job Description

As a Quality Professional/Delegated QP in our External Quality Operations team, you will review and release of API, Drug Product and Finished Product for clinical trials in Europe but also on global level. You will be part of a smaller team of seven people with whom you will work very closely, and you’ll support each other in the daily work. This position reports to the QA manager, External Quality Operations, Clinical. The main QA activities are related to the manufacturing and packaging of clinical products at contract manufacturing organizations (CMO).Primary Responsibilities- Batch record review and disposition of the applicable products - QA assessment and review of Change Controls- Handling of internal and product related exceptions and investigations- Quality improvements and other quality challenges in close collaboration with internal and external stakeholders- Participate in development and maintenance of Quality Systems as applicable - Participate in departmental relevant projects- Ad hoc quality tasks within the department

Qualifications

As a person, you are self-driven, responsible and proactive and able to take ownership of your assignments. Furthermore, you should have;- Experience working within production, Quality Assurance, Quality Control, Regulatory Affairs OR experience working as a Delegated QP within the biotech or pharmaceutical industry - Strong knowledge of GMP - Strong communication skills and fluency in spoken and written EnglishYou are a strong team player who bring a sense of humor and energy to work every day and with good communication skills.

Education

We are looking for a committed and quality-conscious Quality Professional with an educational background which is relevant for becoming trained as a delegated Qualified Person. Preferably you hold a Master’s degree in pharmacy or similar.

 

Employment Category: Full-Time Regular

Experience Level: Associate


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330028156Phoenix-893193e512019-06-03T00:00:00Quality Professional / Delegated QP

Summary

Are you an experienced Quality Professional with a positive and pragmatic attitude? Then you might be the person we are looking for!We are currently looking for a new Quality Professional/Delegated QP to join our External Quality Operations based in Hillerød, Denmark.

Job Category: Quality

Requisition Number: 37488BR

Job Description

As a Quality Professional/Delegated QP in our External Quality Operations team, you will review and release of API, Drug Product and Finished Product for clinical trials in Europe but also on global level. You will be part of a smaller team of seven people with whom you will work very closely, and you’ll support each other in the daily work. This position reports to the QA manager, External Quality Operations, Clinical. The main QA activities are related to the manufacturing and packaging of clinical products at contract manufacturing organizations (CMO).Primary Responsibilities- Batch record review and disposition of the applicable products - QA assessment and review of Change Controls- Handling of internal and product related exceptions and investigations- Quality improvements and other quality challenges in close collaboration with internal and external stakeholders- Participate in development and maintenance of Quality Systems as applicable - Participate in departmental relevant projects- Ad hoc quality tasks within the department

Qualifications

As a person, you are self-driven, responsible and proactive and able to take ownership of your assignments. Furthermore, you should have;- Experience working within production, Quality Assurance, Quality Control, Regulatory Affairs OR experience working as a Delegated QP within the biotech or pharmaceutical industry - Strong knowledge of GMP - Strong communication skills and fluency in spoken and written EnglishYou are a strong team player who bring a sense of humor and energy to work every day and with good communication skills.

Education

We are looking for a committed and quality-conscious Quality Professional with an educational background which is relevant for becoming trained as a delegated Qualified Person. Preferably you hold a Master’s degree in pharmacy or similar.

 

Employment Category: Full-Time Regular

Experience Level: Associate

2019-07-10T16:51:16.453 Summary Are you an experienced Quality Professional with a positive and pragmatic attitude? Then you might be the person we are looking for!We are currently looking for a new Quality Professional Delegated QP to join our External Quality Operations based in Hillerød, Denmark. Job Category: Quality Requisition Number: 37488BR Job Description As a Quality Professional Delegated QP in our External Quality Operations team, you will review and release of API, Drug Product and Finished Product for clinical trials in Europe but also on global level. You will be part of a smaller team of seven people with whom you will work very closely, and you ll support each other in the daily work. This position reports to the QA manager, External Quality Operations, Clinical. The main QA activities are related to the manufacturing and packaging of clinical products at contract manufacturing organizations (CMO).Primary Responsibilities- Batch record review and disposition of the applicable products - QA assessment and review of Change Controls- Handling of internal and product related exceptions and investigations- Quality improvements and other quality challenges in close collaboration with internal and external stakeholders- Participate in development and maintenance of Quality Systems as applicable - Participate in departmental relevant projects- Ad hoc quality tasks within the department Qualifications As a person, you are self-driven, responsible and proactive and able to take ownership of your assignments. Furthermore, you should have - Experience working within production, Quality Assurance, Quality Control, Regulatory Affairs OR experience working as a Delegated QP within the biotech or pharmaceutical industry - Strong knowledge of GMP - Strong communication skills and fluency in spoken and written EnglishYou are a strong team player who bring a sense of humor and energy to work every day and with good communication skills. Education We are looking for a committed and quality-conscious Quality Professional with an educational background which is relevant for becoming trained as a delegated Qualified Person. Preferably you hold a Master s degree in pharmacy or similar. Employment Category: Full-Time Regular Experience Level: Associate11jobnet893193e5100000000000IDK_OFIR_02DKDanmark228DKK2019-07-11T00:00:000000https://sjobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?PageType=JobDetails&partnerid=169&siteid=5140&jobid=8277400EuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3531019BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Idec Alle 13400HillerødDKDanmark0DKDanmarkDKDanmark8Fuldtid46Permanent764477JobNet4992394499239410021-05-20190https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=893193e5https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=893193e5https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=893193e5&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=893193e5&page=EmailApplyForm&component=SendApplicationButtonQuality Professional / Delegated QP1Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige361844628noreply@ofir.comDKDanmarkDKDanmark330107541Associate Manager in Oral Finished Products QCRobot Quality Måløv Associate Manager in Oral Finished Products QC Do you want to join us on a journey where you, as a true pioneer, will break new land, and will be a part of one of Novo Nordisk most interesting projects? Do you have the interest and capabilities to lead a team of highly skilled and ambitious scientists and technicians? Then this is the challenge you are looking for. You can look forward to a job where you will set direction for the future work with oral products, in the new area of Oral Finished Products (OFP) and where your effort will have invaluable importance for the lives of people living with diabetes. About the department Oral Finished Products QC (OFP QC) employs approximately 65 highly skilled and motivated employees and have two missions Analytical support to OFP production and production for launch and market and support to Manufacturing Development, which involves preparing for new oral products in collaboration with CMC and giving analytical support all the way from development to clinical phase 3. This makes our everyday exciting and changeable. The department was established only few years ago, and therefore we are in an ongoing process of setting up and impacting working procedures. In the near future, we are foreseeing exceptional interesting assignments as we just got our first oral diabetes product on the market and already working on the next one. What we do is really innovative and important and in Novo Nordisk, all eyes are on us . We are an agile department and we solve exciting and challenging tasks every day. The position You will be responsible and accountable for one of the analytical teams. You will work to ensure high performance is met and that the team meets project and organisational goals. You will ensure effective resource allocation in your team and you will be the one to encourage and facilitate professional discussions. You will provide leadership and spur continuous development of the team members through coaching and dialogue. You will secure a business focused prioritising of resources and actions and motivate your team towards what is best for both the business and the team. Since we are breaking new land, prioritisation and willingness to adapt to changes and new priorities is key for success. The position requires engagement and high ambition and ability to find solutions in challenging situations. You will be a member of the Management team of OFP QC, and you will participate in cross-organisational projects and collaborations. Moreover, you will lead the way and be a role model in a LEAN culture where openness, honesty and focus on continuous improvements are natural parts of your personality. Qualifications You hold a M.Sc. or equivalent in Pharmacy, Biochemistry, Chemical Engineering, or other relevant scientific discipline. You have an understanding for the analytical field preferably from the pharmaceutical industry. You have strong leadership skills and ability to always take the lead and you focus on deliverables. Preferably you have a minimum of two years people management experience. On a personal level, you contribute positive to our department and enjoy working with people from different professional backgrounds who are dedicated towards meeting our common goals. You are eager to see things moving forward in a dynamic environment where projects and processes vary demanding the need for your flexibility. You work in a structured manner with a non-compromised focus on quality and deliverables. You have a can-do mind-set and focus on opportunities rather than limitations and provide the right balance between leadership and management to your team. You are able to look beyond your own team, cross functional and also have a clear eye and understanding of what is best for both our people and our business. You are a strong communicator and able to communicate complex content to people with different backgrounds and skills, motivating them to hear and follow your ideas and suggestions. Contact For further information, please call, Karoline Benktander 45 30758013 Deadline 10.november 2019 - however applications will be evaluated, and interviews conducted on an ongoing basis so please apply as soon as possible. About Oral Finished Products in Novo Nordisk In 2004 an ambitious and path-breaking journey began for us to become the first medical company delivering GLP-1-based tablets to the market. At this moment we are close to our goal, which means that millions of patients with type-2 diabetes will have an oral alternative to injectable preparation. This is a result of competent, innovative and engaged employees efforts, who are proud to use their dedication to make totally new standards within the diabetes treatment. Join us at our journey a possibility to make a personal and professional development. Working at Novo Nordisk At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Millions rely on us To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
  • Quality
  • Måløv

Associate Manager in Oral Finished Products QC

Do you want to join us on a journey where you, as a true pioneer, will break new land, and will be a part of one of Novo Nordisk most interesting projects?  Do you have the interest and capabilities to lead a team of highly skilled and ambitious scientists and technicians? Then this is the challenge you are looking for.

You can look forward to a job where you will set direction for the future work with oral products, in the new area of Oral Finished Products (OFP) and where your effort will have invaluable importance for the lives of people living with diabetes.

About the department

Oral Finished Products QC (OFP QC) employs approximately 65 highly skilled and motivated employees and have two missions; Analytical support to OFP production and production for launch and market and support to Manufacturing Development, which involves preparing for new oral products in collaboration with CMC and giving analytical support all the way from development to clinical phase 3. This makes our everyday exciting and changeable.

The department was established only few years ago, and therefore we are in an ongoing process of setting up and impacting working procedures. In the near future, we are foreseeing exceptional interesting assignments as we just got our first oral diabetes product on the market and already working on the next one. What we do is really innovative and important and in Novo Nordisk, “all eyes are on us”. We are an agile department and we solve exciting and challenging tasks every day.

The position

You will be responsible and accountable for one of the analytical teams. You will work to ensure high performance is met and that the team meets project and organisational goals. You will ensure effective resource allocation in your team and you will be the one to encourage and facilitate professional discussions. You will provide leadership and spur continuous development of the team members through coaching and dialogue. You will secure a business focused prioritising of resources and actions and motivate your team towards what is best for both the business and the team. Since we are breaking new land, prioritisation and willingness to adapt to changes and new priorities is key for success.

The position requires engagement and high ambition and ability to find solutions in challenging situations.
You will be a member of the Management team of OFP QC, and you will participate in cross-organisational projects and collaborations. Moreover, you will lead the way and be a role model in a LEAN culture where openness, honesty and focus on continuous improvements are natural parts of your personality.

Qualifications

You hold a M.Sc. or equivalent in Pharmacy, Biochemistry, Chemical Engineering, or other relevant scientific discipline. You have an understanding for the analytical field preferably from the pharmaceutical industry. You have strong leadership skills and ability to always take the lead and you focus on deliverables. Preferably you have a minimum of two years people management experience.
On a personal level, you contribute positive to our department and enjoy working with people from different professional backgrounds who are dedicated towards meeting our common goals. You are eager to see things moving forward in a dynamic environment where projects and processes vary demanding the need for your flexibility. You work in a structured manner with a non-compromised focus on quality and deliverables. You have a can-do mind-set and focus on opportunities rather than limitations and provide the right balance between leadership and management to your team. You are able to look beyond your own team, cross functional and also have a clear eye and understanding of what is best for both our people and our business. You are a strong communicator and able to communicate complex content to people with different backgrounds and skills, motivating them to hear and follow your ideas and suggestions. 

Contact

For further information, please call, Karoline Benktander +45 30758013

Deadline

10.november 2019 - however applications will be evaluated, and interviews conducted on an ongoing basis so please apply as soon as possible.
 

About Oral Finished Products in Novo Nordisk

In 2004 an ambitious and path-breaking journey began for us to become the first medical company delivering GLP-1-based tablets to the market. At this moment we are close to our goal, which means that millions of patients with type-2 diabetes will have an oral alternative to injectable preparation. This is a result of competent, innovative and engaged employees’ efforts, who are proud to use their dedication to make totally new standards within the diabetes treatment. Join us at our journey – a possibility to make a personal and professional development.

Working at Novo Nordisk

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Millions rely on us

To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Novo Nordisk A/SMåløv2019-10-15T00:00:002019-11-10T00:00:00
da-DK

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Associate Manager in Oral Finished Products QC

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Quality Måløv Associate Manager in Oral Finished Products QC Do you want to join us on a journey where you, as a true pioneer, will break new land, and will be a part of one of Novo Nordisk most interesting projects? Do you have the interest and cap...
Indrykket:15. oktober 2019
Udløbsdato:10. november 2019