GMP partner
- Production
- Denmark - Gentofte
Do you have in-depth cGMP knowledge and know how to apply it in practise? Are you able to make the right cGMP decisions and set direction for others? Are you motivated by increasing the level of understanding of quality and compliance in the organisation? Then you are the ideal candidate as cGMP-partner to safe guard that our compliance level is up-to-date to current standards in Biopharm API Production.
About the department
We are a production unit located in Gentofte and Kalundborg responsible for production of the Active Pharmaceutical Ingredient (API) of Growth hormone, Factor VII and Glucagon. We are organised in Product Supply, Biopharm, we are 250 colleagues having a challenging and fun working environment. As a GMP partner you will join the management team consisting of three Directors, a cLEAN partner and an assistant. Your role will be to ensure that the compliance level is adequate. This is a primary focus area in Biopharm API. You will also be coordinating the Departmental GMP coordinators work in the unit in terms of establishing systems to follow up on and implement cGMP.
The job
You will together with the management group in BioPharm API be the gate-keeper of the compliance level in the unit and you will be a sparring partner for management and academics in cGMP dilemmas. A key part of your job will be training and mentoring of local GMP coordinators in the departments. During audits and inspections you will be the main responsible in preparing and executing them successfully. You will support departments in ensuring everything from house-keeping to validation is up-to-date and rehearse the most complex issues before presentation at the inspection. Furthermore, you will be key driver and coordinator of the Quality Management Review process. Your daily job will be based in Gentofte, where you will be responsible for planning and following up on the quality systems as well as carrying out quality improvement projects. You will be coordinating the team of GMP coordinators in Biopharm API in order to create best practices and solve new cGMP challenges across the departments. You will be project manager for the completing compliance improvements projects in the unit.
Qualifications
You hold a degree as pharmacist, chemical engineer or equivalent. From your background in Quality Assurance, you have in-depth knowledge of cGMP and ISO 9001 standards and guidelines and have hands-on experience in applying them to a complex production environment. You have excellent communication and interpersonal skills and are able to communicate cGMP and ISO 9001 requirements to management as well as chemists and operators. Your structured personality makes it easy for you to navigate in various IT-systems and constantly keeping the compliance status of the unit up-to-date. You have a positive attitude and are able to balance business criticality without compromising product quality or compliance level. Besides being fluent in Danish you master English on a professional level.
If you want to become our new colleague, we will look forward to receiving you application in Danish or English, as you prefer.
At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference
Contact
For further information, please contact Ulla Grove Sidelmann at + 45 3075 4454.
Deadline
13 December 2013.
- Production
- Denmark - Gentofte
Do you have in-depth cGMP knowledge and know how to apply it in practise? Are you able to make the right cGMP decisions and set direction for others? Are you motivated by increasing the level of understanding of quality and compliance in the organisation? Then you are the ideal candidate as cGMP-partner to safe guard that our compliance level is up-to-date to current standards in Biopharm API Production.
About the department
We are a production unit located in Gentofte and Kalundborg responsible for production of the Active Pharmaceutical Ingredient (API) of Growth hormone, Factor VII and Glucagon. We are organised in Product Supply, Biopharm, we are 250 colleagues having a challenging and fun working environment. As a GMP partner you will join the management team consisting of three Directors, a cLEAN partner and an assistant. Your role will be to ensure that the compliance level is adequate. This is a primary focus area in Biopharm API. You will also be coordinating the Departmental GMP coordinators work in the unit in terms of establishing systems to follow up on and implement cGMP.
The job
You will together with the management group in BioPharm API be the gate-keeper of the compliance level in the unit and you will be a sparring partner for management and academics in cGMP dilemmas. A key part of your job will be training and mentoring of local GMP coordinators in the departments. During audits and inspections you will be the main responsible in preparing and executing them successfully. You will support departments in ensuring everything from house-keeping to validation is up-to-date and rehearse the most complex issues before presentation at the inspection. Furthermore, you will be key driver and coordinator of the Quality Management Review process. Your daily job will be based in Gentofte, where you will be responsible for planning and following up on the quality systems as well as carrying out quality improvement projects. You will be coordinating the team of GMP coordinators in Biopharm API in order to create best practices and solve new cGMP challenges across the departments. You will be project manager for the completing compliance improvements projects in the unit.
Qualifications
You hold a degree as pharmacist, chemical engineer or equivalent. From your background in Quality Assurance, you have in-depth knowledge of cGMP and ISO 9001 standards and guidelines and have hands-on experience in applying them to a complex production environment. You have excellent communication and interpersonal skills and are able to communicate cGMP and ISO 9001 requirements to management as well as chemists and operators. Your structured personality makes it easy for you to navigate in various IT-systems and constantly keeping the compliance status of the unit up-to-date. You have a positive attitude and are able to balance business criticality without compromising product quality or compliance level. Besides being fluent in Danish you master English on a professional level.
If you want to become our new colleague, we will look forward to receiving you application in Danish or English, as you prefer.
At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference
Contact
For further information, please contact Ulla Grove Sidelmann at + 45 3075 4454.
Deadline
13 December 2013.