Substitute - QA for Investigational Medicinal Products, CMC PPF QA
- Research & Development
- Denmark - Måløv
Are you looking for new challenges within QA – development of parenteral bulk product for clinical trials and do you want to make a difference? Since one of our colleagues is going on maternity leave, we have a 14 months temporary position.
About the department
In Parenteral Protein Formulation QA we have the responsibility for quality assurance of parenteral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility of the aseptic pilot production. The CMC development projects include both biopharmaceuticals and diabetes project.
The job
In close cooperation with your colleagues in QA, you act as a consultant for our pilot and formulation departments. The job is a combination of development project and facility related QA tasks. You will approve documentation for development, manufacturing, stability, and release of drug product for clinical trials. You will assure that the development documentation is compliant with internal and external requirements. You will approve facility related documentation needed for the operation of the aseptic pilot plant. 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.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.
Qualifications
Ideally, you have a master in Pharmacy or corresponding qualifications and experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: GMP, validation/qualification, requirements for aseptic production, and requirements for investigational medicinal products for use in clinical trials. You enjoy working in a dynamic environment, where teamwork is at the top of the agenda. Also, you are quite adaptable and challenge our way of doing things, so that we will get even better. You focus on results and quality – and contribute to the right level of compliance.
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 Marion Cathrine Wismann +45 3079 2486.
Deadline
10 September 2013.
- Research & Development
- Denmark - Måløv
Are you looking for new challenges within QA – development of parenteral bulk product for clinical trials and do you want to make a difference? Since one of our colleagues is going on maternity leave, we have a 14 months temporary position.
About the department
In Parenteral Protein Formulation QA we have the responsibility for quality assurance of parenteral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility of the aseptic pilot production. The CMC development projects include both biopharmaceuticals and diabetes project.
The job
In close cooperation with your colleagues in QA, you act as a consultant for our pilot and formulation departments. The job is a combination of development project and facility related QA tasks. You will approve documentation for development, manufacturing, stability, and release of drug product for clinical trials. You will assure that the development documentation is compliant with internal and external requirements. You will approve facility related documentation needed for the operation of the aseptic pilot plant. 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.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.
Qualifications
Ideally, you have a master in Pharmacy or corresponding qualifications and experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: GMP, validation/qualification, requirements for aseptic production, and requirements for investigational medicinal products for use in clinical trials. You enjoy working in a dynamic environment, where teamwork is at the top of the agenda. Also, you are quite adaptable and challenge our way of doing things, so that we will get even better. You focus on results and quality – and contribute to the right level of compliance.
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 Marion Cathrine Wismann +45 3079 2486.
Deadline
10 September 2013.