Sr. QA for Qualification/Validation in Pilot fac., CMC Drug Product
- 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? The pilot facilities are expanding, and therefore we are looking for a dedicated, professional and enthusiastic new colleague.
About the department
The department consists of two teams, Analysis QA and Drug Product QA.
In Drug Product QA we have the responsibility for quality assurance of parenteral and oral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility for operation of the aseptic and oral pilot plant in CMC Supply.
The job
In close cooperation with your colleagues in QA, you act as a consultant for our pilot. You contribute to finding solutions for ad hoc questions and challenges within compliance of the facilities.
The job is related to qualification/validation of equipment in the pilot facilities. You will assure that the documentation for implementation and maintenance of equipment is compliant with internal and external requirements.
Furthermore, you will approve facility related documentation needed for the operation of the plant eg. change request, non-conformities, SOP’s, environmental monitoring and utilities.
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, Chemical Eng. or corresponding qualifications and at least 5 years of experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: GMP, validation/qualification, equipment used in aseptic and solid dosage production.
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 call Janne Lavritsen on +45 3075 7333. or Jens Thorsen on +45 3079 8753.
Deadline
23 June 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? The pilot facilities are expanding, and therefore we are looking for a dedicated, professional and enthusiastic new colleague.
About the department
The department consists of two teams, Analysis QA and Drug Product QA.
In Drug Product QA we have the responsibility for quality assurance of parenteral and oral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility for operation of the aseptic and oral pilot plant in CMC Supply.
The job
In close cooperation with your colleagues in QA, you act as a consultant for our pilot. You contribute to finding solutions for ad hoc questions and challenges within compliance of the facilities.
The job is related to qualification/validation of equipment in the pilot facilities. You will assure that the documentation for implementation and maintenance of equipment is compliant with internal and external requirements.
Furthermore, you will approve facility related documentation needed for the operation of the plant eg. change request, non-conformities, SOP’s, environmental monitoring and utilities.
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, Chemical Eng. or corresponding qualifications and at least 5 years of experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: GMP, validation/qualification, equipment used in aseptic and solid dosage production.
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 call Janne Lavritsen on +45 3075 7333. or Jens Thorsen on +45 3079 8753.
Deadline
23 June 2013.