QA Specialist Assembly & Packaging or Finished Products
Søborg
Join Global Contract Manufacturing (GCM) – Drug Product (DP) QA and contribute with assembly, packaging and compliance specialist experience to CMO assessments, operation support and transfer projects to CMO’s in Europe, the US and Asia.
Our organisation is expanding so we can continue to support the strong volume growth with capacity expansions at CMO’s, a growing R&D pipeline progressing towards markets with CMO supply chains and acquired companies with fully outsourced CMO supply chains.
At the moment, the workplace is in Søborg but at the end of 2024 we will be relocated to Høje Taastrup. The position Do you want to make a real impact on the lives of patients with chronic diseases?
As a Finished Production QA Specialist in GCM QA you will act as GMP adviser and mentor for QA colleagues in QA FP/DP operation and transfer Projects for outsourced production. You will play a pivotal role in the selection and assessment of (Contract Manufacturing Organizations) CMOs and negotiation and implementation of Quality Agreements. Your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
Your main responsibilities will be to: Provide GMP direction to outsourced manufacturing and support the implementation of new quality compliance measures in close collaboration with management. Facilitate critical cases in collaboration with line of Business and Global Contract Manufacturing (GCM) QA colleagues. Expert in validation requirement within validation of assembly and packaging Provide training for QA colleagues. Participate in compliance discussions with Qualified Person (QP), QA Manager and CMO QA management. Drive internal compliance projects to ensure standards for outsourced activities. Be part of selection process including assessment of potential new CMO’s Furthermore, you will contribute to working groups, and projects related to QMS or your core area of expertise, serving as a subject matter expert in GMP and quality matters and by delivering training in quality activities.
The role requires up to 20-30 days of travel per year to primarily CMOs locations outside of Denmark. If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you. Qualifications
To succeed in this role, you: Hold a master’s degree in Pharmacy, Chemistry, Engineering or similar Have strong pharmaceutical industry knowledge and understanding (8+ years of experience) Have significant Quality Assurance experience Have significant Finished product (FP) experience - preferable acquired in Production/QA working with FP processes in assembly and packaging lines covering tasks such as qualification, implementation, and maintenance. Preferably have experience with suppliers in a global environment and technology transfer from development to commercial phase and/or as part of products from one site to another Expertise in quality requirement for contract manufactured products and experience with outsourcing will be seen as an advantage. On a personal level, you are a self-driven and strong team player with excellent problem-solving and communication skills; you are proactive and solution-oriented with a can-do attitude and strategic focus. Finally, your excellent communication skills allow you to engage at all levels of the organization and make independent decisions. About the department Global Contract Manufacturing QA – Drug Product (GCM DP QA) are responsible for product quality and QA Oversight of CMOs and the final batch release of batches produced externally.
At the moment the department consists of 40 highly qualified employees in 4 different teams, but we are growing very fast and expecting to become bigger in the nearest future. You will be a strong player in the QA DP Support team together with other team members including 6 QA specialists and the cLEAN partner for the VP area. The department is characterised by a high level of professionalism, flexibility, and cooperation.
We can offer a great working environment with high level of team spirit as well as a highly skilled team of ambitious and engaged colleagues. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area. We focus on good social relations and prioritise to make room for fun at work. 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 QA Manager Marianne Hjulgaard on +or QA Specialist Anne Friis +
Deadline
23rd June 2024 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.
Our organisation is expanding so we can continue to support the strong volume growth with capacity expansions at CMO’s, a growing R&D pipeline progressing towards markets with CMO supply chains and acquired companies with fully outsourced CMO supply chains.
At the moment, the workplace is in Søborg but at the end of 2024 we will be relocated to Høje Taastrup. The position Do you want to make a real impact on the lives of patients with chronic diseases?
As a Finished Production QA Specialist in GCM QA you will act as GMP adviser and mentor for QA colleagues in QA FP/DP operation and transfer Projects for outsourced production. You will play a pivotal role in the selection and assessment of (Contract Manufacturing Organizations) CMOs and negotiation and implementation of Quality Agreements. Your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations.
Your main responsibilities will be to:
The role requires up to 20-30 days of travel per year to primarily CMOs locations outside of Denmark. If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you. Qualifications
To succeed in this role, you:
At the moment the department consists of 40 highly qualified employees in 4 different teams, but we are growing very fast and expecting to become bigger in the nearest future. You will be a strong player in the QA DP Support team together with other team members including 6 QA specialists and the cLEAN partner for the VP area. The department is characterised by a high level of professionalism, flexibility, and cooperation.
We can offer a great working environment with high level of team spirit as well as a highly skilled team of ambitious and engaged colleagues. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area. We focus on good social relations and prioritise to make room for fun at work. 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 QA Manager Marianne Hjulgaard on +or QA Specialist Anne Friis +
Deadline
23rd June 2024 You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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 Søborg.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg