Sr. QA Professional, Cleaning and Qualification/Validation in Pilot Pl
- Research & Development
- Denmark - Gentofte
Are you looking for new challenges within QA – and do you strive for making a difference in assuring the quality of facilities and equipment in CMC API Development, especially cleaning in multi-purpose facilities?
Can you combine your knowledge of quality and pharmaceutical production with your drive for results?
Do you want ensure the quality of Novo Nordisk new products for clinical development?
About the department
CMC API QA has the responsibility of assuring that API (Active Pharmaceutical Ingredients) activities in development and support projects in Novo Nordisk A/S fullfill cGMP requirements.
The department consists of 29 employees organised into two teams. You will be a part of the Process Compliance Team (PC-Team) in CMC API QA. You will join a team of 10 dedicated colleagues assuring that our pilot plants (cell banks, cell cultivation, purification and chemical synthesis) and development laboratories meet the internal and external requirements.
The pilot plants and the development laboratories are located in Bagsværd, Gentofte, Måløv and Hillerød. During the week you will be moving between the different locations and the QA office. This way of working requires that you have the ability to be a team player on distance.
The job
With responsibility of one or several of our pilot plants you will be in charge of assuring quality of our production areas with regards to validation and qualification of equipment, environment and utilities. Document approval in connection with qualification, cleaning, maintenance and improvement of the quality system (SOP’s) and other documentation from the facility, will be included in your daily tasks. In addition, you will have focus on aspects with regards to cleaning of equipment across facilities and CMC QA. You will have a broad interface within the organisation and a dynamic working week with varying tasks.
CMC Supply’s continuing high level of audit and inspection readiness is on top of your agenda.
In CMC Supply QA we work with QA oversight where you, in close cooperation with your colleagues, will identify and contribute to the strengthening of our stakeholders’ compliance.
The responsibility of maintenance and improvement of the quality systems is also based on close cooperation between the pilot plants and QA. Great interpersonal skills and high spirits will therefore be a necessity. In cooperation with your colleagues in QA, you act as a consultant for our pilot plant and you will experience a lot of time spend on competent feedback with internal in QA colleagues and colleagues from the pilot plants.
We operate in a LEAN orientated environment and you will have the opportunity to contribute with ideas and improvements and to drive the implementation of these. Working within QA your professional and individual skills will be challenged and you will find that your tasks will include many different clinical stages in the product development.
Qualifications
Ideally, you have a master in Pharmacy, Chemical Eng. or corresponding qualifications and a strong quality mindset. You have at least 6 years of experience and knowledge of GMP, equipment / facilitation, qualification and cleaning from a QA area working in pilot plants or production. As we operate in an international environment you will have to master fluent English - both spoken and written.
Personally, you are ambitious and focus on results and quality – and you contribute to the right level of compliance. You are decisive and embrace complex tasks via constructive dialogue and in cooperation with QA colleagues and collaborators in the pilot plants. Also, you thrive in a role where you use your knowledge and bring your arguments and negotiation skills in to play. You are able to adapt and challenge our way of doing things, so that we will get even better.
At Novo Nordisk, 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.
Contact
For further information, please contact Lisbeth Voetmann +45 3075 0530 or Peter Søtofte Elten at +45 3079 8453.
Deadline
23 June 2013.
- Research & Development
- Denmark - Gentofte
Are you looking for new challenges within QA – and do you strive for making a difference in assuring the quality of facilities and equipment in CMC API Development, especially cleaning in multi-purpose facilities?
Can you combine your knowledge of quality and pharmaceutical production with your drive for results?
Do you want ensure the quality of Novo Nordisk new products for clinical development?
About the department
CMC API QA has the responsibility of assuring that API (Active Pharmaceutical Ingredients) activities in development and support projects in Novo Nordisk A/S fullfill cGMP requirements.
The department consists of 29 employees organised into two teams. You will be a part of the Process Compliance Team (PC-Team) in CMC API QA. You will join a team of 10 dedicated colleagues assuring that our pilot plants (cell banks, cell cultivation, purification and chemical synthesis) and development laboratories meet the internal and external requirements.
The pilot plants and the development laboratories are located in Bagsværd, Gentofte, Måløv and Hillerød. During the week you will be moving between the different locations and the QA office. This way of working requires that you have the ability to be a team player on distance.
The job
With responsibility of one or several of our pilot plants you will be in charge of assuring quality of our production areas with regards to validation and qualification of equipment, environment and utilities. Document approval in connection with qualification, cleaning, maintenance and improvement of the quality system (SOP’s) and other documentation from the facility, will be included in your daily tasks. In addition, you will have focus on aspects with regards to cleaning of equipment across facilities and CMC QA. You will have a broad interface within the organisation and a dynamic working week with varying tasks.
CMC Supply’s continuing high level of audit and inspection readiness is on top of your agenda.
In CMC Supply QA we work with QA oversight where you, in close cooperation with your colleagues, will identify and contribute to the strengthening of our stakeholders’ compliance.
The responsibility of maintenance and improvement of the quality systems is also based on close cooperation between the pilot plants and QA. Great interpersonal skills and high spirits will therefore be a necessity. In cooperation with your colleagues in QA, you act as a consultant for our pilot plant and you will experience a lot of time spend on competent feedback with internal in QA colleagues and colleagues from the pilot plants.
We operate in a LEAN orientated environment and you will have the opportunity to contribute with ideas and improvements and to drive the implementation of these. Working within QA your professional and individual skills will be challenged and you will find that your tasks will include many different clinical stages in the product development.
Qualifications
Ideally, you have a master in Pharmacy, Chemical Eng. or corresponding qualifications and a strong quality mindset. You have at least 6 years of experience and knowledge of GMP, equipment / facilitation, qualification and cleaning from a QA area working in pilot plants or production. As we operate in an international environment you will have to master fluent English - both spoken and written.
Personally, you are ambitious and focus on results and quality – and you contribute to the right level of compliance. You are decisive and embrace complex tasks via constructive dialogue and in cooperation with QA colleagues and collaborators in the pilot plants. Also, you thrive in a role where you use your knowledge and bring your arguments and negotiation skills in to play. You are able to adapt and challenge our way of doing things, so that we will get even better.
At Novo Nordisk, 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.
Contact
For further information, please contact Lisbeth Voetmann +45 3075 0530 or Peter Søtofte Elten at +45 3079 8453.
Deadline
23 June 2013.