QA Project Specialist
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Søborg
Are you looking for a place to feed your enthusiasm for quality? Are you excited about playing a crucial role in ensuring quality processes in ’s global network of Contract Manufacturer Organizations (CMOs)?
Then you can look forward to a leading role where your efforts can make a positive and direct difference every day, apply now to become our new QA Project Specialist! The position
In this position you will be the QA representative in project transfers from to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Main responsibilities include: Quality responsibility for the technical transfer to the CMOs in market and capacity expansion projects and be responsible for setting the quality and compliance direction Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements You will promote good collaboration with the CMO as well as build the Quality mind-set and Compliance culture at the CMO, including activities such as to train the local CMO QA organization to maintain and improve compliant operation and to act as both coach and mentor at the CMO’s Negotiation and implementation of quality agreements, approving process validation strategy and related documents Setting up the QA processes for commercial manufacturing. Participating in qualification audits performed at the CMO and ensure sufficient follow up on CAPAs
Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation.
Expected travel is around 25 days a year as the CMOs are located outside Denmark. We are currently collaboration with CMO’s in Europe, North America, Saudi Arabia, India, Bangladesh and South Africa and we are exploring opportunities in other countries.
You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. Qualifications To succeed in this role, you: hold an academic degree as Pharmacist, Engineer or similar have a minimum of 5 years' experience from the pharmaceutical industry either from production or QA have a solid and up-to-date knowledge of quality and GMP requirements and have the ability to take decisions on quality representing are proficient in English and knowledge of other languages will be an advantage
It is an advantage if you have extensive knowledge within aseptic Drug Products.
On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humor to our department.
Finally, you meet own deadlines and know how to prioritize between different tasks in an everchanging environment. About the department
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. In LMCO QA one of the primary roles is to deliver QA support and set direction for CMO’s in countries where local presence is required to maintain market access.
GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs.
We focus on good social relations and prioritize to make room for fun at work. At the moment, the workplace is in Søborg but in February 2025 we will be relocated to Høje Taastrup.
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 Senior Quality Manager Asger Laurberg Vig +.
Deadline
27 October 2024 Please apply as soon as possible, as we are conducting interviews on an ongoing basis.
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.
Then you can look forward to a leading role where your efforts can make a positive and direct difference every day, apply now to become our new QA Project Specialist! The position
In this position you will be the QA representative in project transfers from to CMOs. You will participate in various projects within Drug Products and Finished Products, working with both internal and external business partners and with a high level of complexity and independent decision making in your daily tasks. Main responsibilities include:
Moreover, you will manage quality issues during the technical transfer such as: Process validation documentation, deviations, out of specifications, change controls, action plan and follow up, evaluate production documentation.
Expected travel is around 25 days a year as the CMOs are located outside Denmark. We are currently collaboration with CMO’s in Europe, North America, Saudi Arabia, India, Bangladesh and South Africa and we are exploring opportunities in other countries.
You will have great professional and personal development opportunities in a well-functioning department. We can offer you a working environment with a high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. Qualifications To succeed in this role, you:
It is an advantage if you have extensive knowledge within aseptic Drug Products.
On a personal level, you have a natural ability to take lead and work as a team player, proactively contributing to the team’s tasks and activities. You have the ability to work in an international set-up with external stakeholders with different interests and agendas, using your great communication and collaboration skills. We would enjoy welcoming a straightforward person with a good sense of humor to our department.
Finally, you meet own deadlines and know how to prioritize between different tasks in an everchanging environment. About the department
Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. In LMCO QA one of the primary roles is to deliver QA support and set direction for CMO’s in countries where local presence is required to maintain market access.
GCM QA is a dynamic department consisting of 70 competent people divided into 8 teams with focus on either operations or projects. You will be a strong player in the project team. The department is characterized by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs.
We focus on good social relations and prioritize to make room for fun at work. At the moment, the workplace is in Søborg but in February 2025 we will be relocated to Høje Taastrup.
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 Senior Quality Manager Asger Laurberg Vig +.
Deadline
27 October 2024 Please apply as soon as possible, as we are conducting interviews on an ongoing basis.
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.
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
- Søborg
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