Quality Control Chemist
Gentofte
Are you driven by continuous optimisation and securing high level of compliance? Are you highly motivated to work in an analytical laboratory and ensure fast delivery of quality products to our patients? We are currently seeking Quality Control (QC) Chemist to join our Biotech & Rare Disease QC in Gentofte and it might be you! If you are as ambitious as we are, you can look forward to an exciting job in an environment where we always strive to be the best in class in everything we do.
The position
As QC Chemist, your primary responsibility will be to write, review analytical protocols and reports for Stability Studies and support laboratory technicians by providing guidance and coaching, securing timely delivery of Samples, Protocols and Reports.
You will work closely with other chemists in the team to ensure that the Stability Studies, References samples, Customer complaints and equipment live up to industry standards and GMP requirements. Your primary tasks will be:
• Support stability, reference samples, and climate facility processes.
• Support with Customer Complaints
• Prepare and review SOPs, , stability protocols and reports, Annual Product Review (APR), Annual Report (AR), and other documents and tasks based on specific process and cGMP knowledge.
• Write and Review Deviations and Change control.
• Perform Systemmatic Problem Solving to identify i root causes and actions to prevent the DV to reoccur.
• Continuous improvement and optimisation of our processes using LEAN principles.
• Present documents at audit/inspections.
• Coordination an Planning activities to support the Team.
You can look forward to an exciting and varied job, that is critical to helping the team achieve its goals. As a team, we are always looking to work smarter and to implement digital and innovative improvements in our processes.
You will have the opportunity to shape your daily routine and responsibilities while also having room for personal and professional development. You will drive day-to-day operations with involvement in project work. This could also be your opportunity to build a strong network within while developing your skills further. Qualifications
You will be a great asset to our team because you have:
• A degree in chemistry, pharmacy, or a similar field with ideally, ideally with several years of experience in manufacturing or quality departments.
• Working with GMP standards, experience working in the pharmaceutical industry is advantageous.
• Good communication skills with stakeholder management experience.
• It is advantageous if you have experience with LEAN.
• Professional proficiency in both written and spoken English. Knowledge of Danish is advantageous but not essential. As an individual, you can work independently and see yourself as being self-driven, responsible, and having an open-minded approach. In addition, it’s natural for you to take the initiative, good at creating an overview and have the courage to solve new types of tasks both individually and in collaboration with colleagues and stakeholders. You can prioritise your tasks and work with documentation in a structured manner to keep an overview of your workload. About the department
Biotech & Rare Disease (BRD) is part of , which delivers products for treatment of rare blood and endocrine disorders. BRD QC consist of six departments supporting our production facilities by performing QC analysis on the whole product portfolio in BRD.
Our department's area of responsibility is chemical, biological and general compendial analysis of stability samples, drug substance samples, drug product samples and intermediate samples. In our QC department in Gentofte, we are approximately 120 motivated and talented colleagues divided into 6 teams. Your new department is characterized by high professionalism, quality mindset and an informal tone.
Working at BRD,
BRD is part of Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for . We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support 's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, you are welcome to contact Nihal Gunasinghe, Associate Manager, at Deadline
16 June 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying for this job 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.
The position
As QC Chemist, your primary responsibility will be to write, review analytical protocols and reports for Stability Studies and support laboratory technicians by providing guidance and coaching, securing timely delivery of Samples, Protocols and Reports.
You will work closely with other chemists in the team to ensure that the Stability Studies, References samples, Customer complaints and equipment live up to industry standards and GMP requirements. Your primary tasks will be:
• Support stability, reference samples, and climate facility processes.
• Support with Customer Complaints
• Prepare and review SOPs, , stability protocols and reports, Annual Product Review (APR), Annual Report (AR), and other documents and tasks based on specific process and cGMP knowledge.
• Write and Review Deviations and Change control.
• Perform Systemmatic Problem Solving to identify i root causes and actions to prevent the DV to reoccur.
• Continuous improvement and optimisation of our processes using LEAN principles.
• Present documents at audit/inspections.
• Coordination an Planning activities to support the Team.
You can look forward to an exciting and varied job, that is critical to helping the team achieve its goals. As a team, we are always looking to work smarter and to implement digital and innovative improvements in our processes.
You will have the opportunity to shape your daily routine and responsibilities while also having room for personal and professional development. You will drive day-to-day operations with involvement in project work. This could also be your opportunity to build a strong network within while developing your skills further. Qualifications
You will be a great asset to our team because you have:
• A degree in chemistry, pharmacy, or a similar field with ideally, ideally with several years of experience in manufacturing or quality departments.
• Working with GMP standards, experience working in the pharmaceutical industry is advantageous.
• Good communication skills with stakeholder management experience.
• It is advantageous if you have experience with LEAN.
• Professional proficiency in both written and spoken English. Knowledge of Danish is advantageous but not essential. As an individual, you can work independently and see yourself as being self-driven, responsible, and having an open-minded approach. In addition, it’s natural for you to take the initiative, good at creating an overview and have the courage to solve new types of tasks both individually and in collaboration with colleagues and stakeholders. You can prioritise your tasks and work with documentation in a structured manner to keep an overview of your workload. About the department
Biotech & Rare Disease (BRD) is part of , which delivers products for treatment of rare blood and endocrine disorders. BRD QC consist of six departments supporting our production facilities by performing QC analysis on the whole product portfolio in BRD.
Our department's area of responsibility is chemical, biological and general compendial analysis of stability samples, drug substance samples, drug product samples and intermediate samples. In our QC department in Gentofte, we are approximately 120 motivated and talented colleagues divided into 6 teams. Your new department is characterized by high professionalism, quality mindset and an informal tone.
Working at BRD,
BRD is part of Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for . We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support 's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, you are welcome to contact Nihal Gunasinghe, Associate Manager, at Deadline
16 June 2024. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying for this job 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 Gentofte.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Gentofte