QA Principal Scientist in API
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Kalundborg
Do you have a strong quality mindset and production understanding in a GMP regulated area? Can you optimise and simplify processes and are you eager to create continuous improvements in a dynamic organisation? Are you strong in presenting difficult issues also at inspections from authorities? Then you might be our new Principal Scientist in Active Pharmaceutical Ingredients (API) Quality Assurance (QA).
This is a rarely offered position with great possibilities to set your footprint on our processes, both within daily operation and projects, so apply now!
The position
We are looking for a QA Principal Scientist with solid GMP knowledge to set direction within quality across API QA. This is the right role for you, if you have a great interest in production processes, production projects and collaboration.
Among your responsibilities, you will: Support your colleagues as well as our stakeholders in the production areas. Serve as a daily sparring partner and coach for your colleagues, and as such you must have a good overview of ongoing tasks and deliveries. Participate in production projects, ensure QA oversight. Be QA responsible for various tasks within the organisation.
In other words, it is a requirement that you will be visible in API QA, being a person that colleagues and management will rely on with your high integrity and good business understanding. You will have a broad stakeholder landscape to navigate in, both across and within the quality organisation. You will be setting scientific direction within quality assurance together with the management team, which you will be a member of. Qualifications You have a passion for quality and are recognized as a subject matter expert within compliance and quality assurance in pharmaceutical industry and use with ability your stakeholder interaction experience, in order to manage multiple interests and changing objectives. To succeed in this role, you: Hold a Master´s degree in pharmacy, engineering or natural science Have minimum 5 years of relevant experience from the pharma industry within e.g. QA or API production Have experience and are passionate about general GMP, process optimization, problem solving in a pharmaceutical company. Have strong knowledge of QA methods, processes and regulations. Are fully proficient in English
You are attracted by the opportunity to use your deep knowledge and skills in a highly complex and ever-changing working environment.
As a person, you thrive in sharing your professional insights and have the communication skills to function as a source of knowledge and a mentor for dedicated colleagues across the organisation, therefore experience with teaching and coaching will be an advantage.
About the department
In this position, you will be based in the QA Manufacturing II (M2) department which is responsible for assuring the quality of the API and intermediates manufactured. We perform a wide range of quality assurance activities, ranging from handling deviations, change requests, validation to quality support to optimization projects in a large CVP production area with several factories and multiple processes. We have a great collaboration with our colleagues in the production and value a high degree of flexibility and individual responsibility. The department consists of 56 highly dedicated and qualified employees divided into four teams. The site in Kalundborg is a small city, about 60 minutes from Copenhagen and Odense. Here, thousands of colleagues work together to deliver quality products to millions of people around the world living with chronical diseases – manufacturing more than half of the entire global supply of insulin. We take pride in applying our skills and our dedication towards the mission of helping people, and we enjoy a healthy and good-spirited work environment with many opportunities for personal and professional development.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Interim Director Rasmus Daugaard Madsen at +or at
Deadline
06 October 2024
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
This is a rarely offered position with great possibilities to set your footprint on our processes, both within daily operation and projects, so apply now!
The position
We are looking for a QA Principal Scientist with solid GMP knowledge to set direction within quality across API QA. This is the right role for you, if you have a great interest in production processes, production projects and collaboration.
Among your responsibilities, you will:
In other words, it is a requirement that you will be visible in API QA, being a person that colleagues and management will rely on with your high integrity and good business understanding. You will have a broad stakeholder landscape to navigate in, both across and within the quality organisation. You will be setting scientific direction within quality assurance together with the management team, which you will be a member of. Qualifications You have a passion for quality and are recognized as a subject matter expert within compliance and quality assurance in pharmaceutical industry and use with ability your stakeholder interaction experience, in order to manage multiple interests and changing objectives. To succeed in this role, you:
You are attracted by the opportunity to use your deep knowledge and skills in a highly complex and ever-changing working environment.
As a person, you thrive in sharing your professional insights and have the communication skills to function as a source of knowledge and a mentor for dedicated colleagues across the organisation, therefore experience with teaching and coaching will be an advantage.
About the department
In this position, you will be based in the QA Manufacturing II (M2) department which is responsible for assuring the quality of the API and intermediates manufactured. We perform a wide range of quality assurance activities, ranging from handling deviations, change requests, validation to quality support to optimization projects in a large CVP production area with several factories and multiple processes. We have a great collaboration with our colleagues in the production and value a high degree of flexibility and individual responsibility. The department consists of 56 highly dedicated and qualified employees divided into four teams. The site in Kalundborg is a small city, about 60 minutes from Copenhagen and Odense. Here, thousands of colleagues work together to deliver quality products to millions of people around the world living with chronical diseases – manufacturing more than half of the entire global supply of insulin. We take pride in applying our skills and our dedication towards the mission of helping people, and we enjoy a healthy and good-spirited work environment with many opportunities for personal and professional development.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Interim Director Rasmus Daugaard Madsen at +or at
Deadline
06 October 2024
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kalundborg.
Jobbet er oprettet på vores service den 12.9.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Kalundborg
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