QA Professional, CMC Analysis QA
- Research & Development
- Denmark - Måløv
Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical development environment? If so, please apply for the position as QA Professional in a job that includes many different clinical stages of the product development.
About the department
In Chemistry, Manufacturing & Control (CMC) Analysis QA we ensure that all analysis activities for all Novo Nordisk development projects live up to cGMP requirements.
We are 11 highly dedicated colleagues in the department located in R&D in Måløv. Our mission is to assure that all our analysis development processes and development laboratories meet the internal and external requirements.
The job
In close cooperation with your colleagues in QA, you act as a consultant for our analytical development departments. You contribute to find solutions for ad hoc questions and challenges within compliance of the analytical development activities. You will approve qualification and validation documentation from analytical departments in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials. You have a risk based approach to the development process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.
We operate in a LEAN-dominated environment, and you will have the opportunity to contribute with ideas for improvements and drive the subsequent implementation as well. Working within QA will definitely challenge your professional and individual skills.
CMC Supply’s continuing high level of audit and inspection readiness is on top on your agenda.
In CMC Supply QA we work with QA oversight where you proactive together with your colleagues will identify areas where our stakeholders’ compliance can be strengthened.
Qualifications
You hold a Master’s degree in Pharmacy or possess equivalent qualifications besides a strong quality mindset. You have at least 3 years of experience. The ideal candidate has thorough knowledge within following areas: GMP, analysis validation, analysis equipment qualification, regulatory requirements to analysis for investigational medicinal products for use in clinical trials and LEAN skills. Preferably you have a solid experience within IT equipment system regulatory requirements. You are fluent written and spoken English on a professional level.
You are good at building relations to colleagues and stakeholders across the organisation. You possess power of determination and are not afraid to handle complex tasks through a constructive dialog and teamwork with your colleagues as partners. In addition, you are able to deliver in due time to meet our customers’ expectations. You are a team player and a skilled communicator, and you thrive on unfolding your high level of energy and knowledge in an international, dynamic environment. You are able to adapt but also challenge our way of working so that we constantly improve our methods and processes.
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 Pernille Uldall Bolvig on +45 3079 7548.
Deadline
1 September 2013.
- Research & Development
- Denmark - Måløv
Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical development environment? If so, please apply for the position as QA Professional in a job that includes many different clinical stages of the product development.
About the department
In Chemistry, Manufacturing & Control (CMC) Analysis QA we ensure that all analysis activities for all Novo Nordisk development projects live up to cGMP requirements.
We are 11 highly dedicated colleagues in the department located in R&D in Måløv. Our mission is to assure that all our analysis development processes and development laboratories meet the internal and external requirements.
The job
In close cooperation with your colleagues in QA, you act as a consultant for our analytical development departments. You contribute to find solutions for ad hoc questions and challenges within compliance of the analytical development activities. You will approve qualification and validation documentation from analytical departments in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials. You have a risk based approach to the development process and product, and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.
We operate in a LEAN-dominated environment, and you will have the opportunity to contribute with ideas for improvements and drive the subsequent implementation as well. Working within QA will definitely challenge your professional and individual skills.
CMC Supply’s continuing high level of audit and inspection readiness is on top on your agenda.
In CMC Supply QA we work with QA oversight where you proactive together with your colleagues will identify areas where our stakeholders’ compliance can be strengthened.
Qualifications
You hold a Master’s degree in Pharmacy or possess equivalent qualifications besides a strong quality mindset. You have at least 3 years of experience. The ideal candidate has thorough knowledge within following areas: GMP, analysis validation, analysis equipment qualification, regulatory requirements to analysis for investigational medicinal products for use in clinical trials and LEAN skills. Preferably you have a solid experience within IT equipment system regulatory requirements. You are fluent written and spoken English on a professional level.
You are good at building relations to colleagues and stakeholders across the organisation. You possess power of determination and are not afraid to handle complex tasks through a constructive dialog and teamwork with your colleagues as partners. In addition, you are able to deliver in due time to meet our customers’ expectations. You are a team player and a skilled communicator, and you thrive on unfolding your high level of energy and knowledge in an international, dynamic environment. You are able to adapt but also challenge our way of working so that we constantly improve our methods and processes.
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 Pernille Uldall Bolvig on +45 3079 7548.
Deadline
1 September 2013.