Advanced QA Professional - Biotech & Rare Disease Finished Products
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Kalundborg
Do you want to be a part of quality assurance (QA) of Biotech & Rare Disease finished products and have broad contact with production? Then you have the opportunity to join our team where you can make an impact. The position We are 13 QA Professionals who have close contact to our production department. Our main responsibilities are to set direction for quality and compliance due to internal and external requirements and release batches for the market. We are offering an exciting and challenging job where you will become part of a competent team which values teamwork and sparring regarding quality issues. In this role your main responsibilities will be: • Reviewing e.g. batch documentation, SOPs and deviations. This is the main content of the job.
• Taking on the role as QP delegate, releasing batches after ended production.
• QA presence: being physically present on the production lines during production to observe processes and help solve issues in real time.
• Advising stakeholders to keep the right level of quality in the production processes.
• Participating and presenting cases when we are inspected from authorities from around the world.
• Improving processes in own QA area. In this job you will get the opportunity to make an impact for our patients as we release products to the marketed for benefit for our patients.
As new employee you will be trained to quickly become part of the daily tasks.
We generally offer flexible hours. Flexible hours are suspended, and overtime can be necessary once in a while due to projects, authority inspections and audits.
Qualifications To be successful in this role we expect you to have: • An academic degree within Ms. Pharmacy, medicine veterinary medicine, Chemistry, Pharmaceutical chemistry and or technology or Biology.
• 2+ years of experience within QA or other relevant GMP related job like GMP coordinator.
• The ability to make decisions based on your GMP knowledge and experience.
• Fluency in written and spoken Danish and English. On a personal level you need to have an eye for details, to be dedicated and engaged and to be able to build strong relations in order to make solid cooperation across the departments. A positive attitude is an absolute necessity as we are the last step before the product reaches our patients, we should be able to deliver with short notice.
We always have space for humour and fun and value relaxed working environment.
About the department Biotech & Rare Disease Quality Assurance Finished Products Kalundborg, is a department in a rapid development. We are QA for Biotech & Rare Disease packaging department who is producing haemophilia products and glucagon. It is us who sets the direction for quality of products in development and production to market and we ensure that the production is in compliance with all requirements and regulations at all times. The department has a very good cooperation both internally and with the rest of Biotech & Rare Disease QA as well as with production and stakeholders. We are engaged in our jobs, have a lot of positive attitudes and an open and honest communication.
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 on the position, feel free to contact Hiring Manager Leyla Okutan on
+.
Deadline 26 May 2024. Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified. 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.
• Taking on the role as QP delegate, releasing batches after ended production.
• QA presence: being physically present on the production lines during production to observe processes and help solve issues in real time.
• Advising stakeholders to keep the right level of quality in the production processes.
• Participating and presenting cases when we are inspected from authorities from around the world.
• Improving processes in own QA area. In this job you will get the opportunity to make an impact for our patients as we release products to the marketed for benefit for our patients.
As new employee you will be trained to quickly become part of the daily tasks.
We generally offer flexible hours. Flexible hours are suspended, and overtime can be necessary once in a while due to projects, authority inspections and audits.
Qualifications To be successful in this role we expect you to have: • An academic degree within Ms. Pharmacy, medicine veterinary medicine, Chemistry, Pharmaceutical chemistry and or technology or Biology.
• 2+ years of experience within QA or other relevant GMP related job like GMP coordinator.
• The ability to make decisions based on your GMP knowledge and experience.
• Fluency in written and spoken Danish and English. On a personal level you need to have an eye for details, to be dedicated and engaged and to be able to build strong relations in order to make solid cooperation across the departments. A positive attitude is an absolute necessity as we are the last step before the product reaches our patients, we should be able to deliver with short notice.
We always have space for humour and fun and value relaxed working environment.
About the department Biotech & Rare Disease Quality Assurance Finished Products Kalundborg, is a department in a rapid development. We are QA for Biotech & Rare Disease packaging department who is producing haemophilia products and glucagon. It is us who sets the direction for quality of products in development and production to market and we ensure that the production is in compliance with all requirements and regulations at all times. The department has a very good cooperation both internally and with the rest of Biotech & Rare Disease QA as well as with production and stakeholders. We are engaged in our jobs, have a lot of positive attitudes and an open and honest communication.
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 on the position, feel free to contact Hiring Manager Leyla Okutan on
+.
Deadline 26 May 2024. Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified. 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 10.5.2024, 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.
- 10.05.2024
- Øvrige
- Kalundborg
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|---|---|
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