Technical Quality Specialist – Pilot Plant & Solid Dosage Form focus
- Research & Development
- Denmark - Måløv
Do you have the skills and the dedication it takes to break new land within diabetes treatment? If so, you now have the opportunity to join our quest for developing break-through products based on orally available versions of insulin and GLP-1. Your knowledge will be put to the test when you are involved in CMC quality and qualification activities for pilot production of solid protein dosage forms towards clinical trials.
About the department
We are 34 colleagues in two teams. We are responsible for development and manufacturing of oral protein products for preclinical and clinical trials. The department covers a broad and exciting range of process technologies for solid dosage forms, technical support, and project management and execution related to qualification of equipment, utilities and facility.
The job
Overall, you will play a key role in expanding our quality competency base within the solid dosage form area in particular within qualification of equipment, utilities and facility. This will involve insurance of the right quality within our equipment flow matrix, from project feasibility start to release for GMP production, including, risk analysis, impact assessment, URS, user instruction and DQ, IQ, OQ, and PQ qualification.
You will be responsible for ensuring the fulfilment of clear quality goals and you set the quality direction and purpose for your colleagues – and you follow up in order to ensure that the department is in compliance with the authorities’ and Novo Nordisk’s regulations. As such, you bring in the latest knowledge within GMP when you challenge our specialists, scientists, technicians, technical coordinators, line management and external contractors to bring GMP and quality to the top of the agenda.
Qualifications
You have a Master’s degree in Pharmacy, Engineering, Chemistry or a related field and at least 5 years of experience from a pharmaceutical production company, where you have gained solid experience within, GMP standards for solid dosage forms. This is topped with experience from qualification of equipment, facility and utilities. In addition, it is important to have experience in computer validation compliance, a good understanding of GMP methodologies and risk analysis.
First and foremost, you have an excellent quality mindset, good communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way. As a person you are known for being highly committed to finding constructive solutions as well as taking responsibility for your assignments. You have an excellent overview, a structured mindset, a dedicated way of working, very good communication skills and ability to balance between when to compromise and when to stand firm.
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.
Contact
For further information please contact Thomas Berg at +45 3075 9520or Lone Løgstrup Kimer at +45 3079 3569.
Deadline
23 March 2014.
- Research & Development
- Denmark - Måløv
Do you have the skills and the dedication it takes to break new land within diabetes treatment? If so, you now have the opportunity to join our quest for developing break-through products based on orally available versions of insulin and GLP-1. Your knowledge will be put to the test when you are involved in CMC quality and qualification activities for pilot production of solid protein dosage forms towards clinical trials.
About the department
We are 34 colleagues in two teams. We are responsible for development and manufacturing of oral protein products for preclinical and clinical trials. The department covers a broad and exciting range of process technologies for solid dosage forms, technical support, and project management and execution related to qualification of equipment, utilities and facility.
The job
Overall, you will play a key role in expanding our quality competency base within the solid dosage form area in particular within qualification of equipment, utilities and facility. This will involve insurance of the right quality within our equipment flow matrix, from project feasibility start to release for GMP production, including, risk analysis, impact assessment, URS, user instruction and DQ, IQ, OQ, and PQ qualification.
You will be responsible for ensuring the fulfilment of clear quality goals and you set the quality direction and purpose for your colleagues – and you follow up in order to ensure that the department is in compliance with the authorities’ and Novo Nordisk’s regulations. As such, you bring in the latest knowledge within GMP when you challenge our specialists, scientists, technicians, technical coordinators, line management and external contractors to bring GMP and quality to the top of the agenda.
Qualifications
You have a Master’s degree in Pharmacy, Engineering, Chemistry or a related field and at least 5 years of experience from a pharmaceutical production company, where you have gained solid experience within, GMP standards for solid dosage forms. This is topped with experience from qualification of equipment, facility and utilities. In addition, it is important to have experience in computer validation compliance, a good understanding of GMP methodologies and risk analysis.
First and foremost, you have an excellent quality mindset, good communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way. As a person you are known for being highly committed to finding constructive solutions as well as taking responsibility for your assignments. You have an excellent overview, a structured mindset, a dedicated way of working, very good communication skills and ability to balance between when to compromise and when to stand firm.
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.
Contact
For further information please contact Thomas Berg at +45 3075 9520or Lone Løgstrup Kimer at +45 3079 3569.
Deadline
23 March 2014.