Are you a strong Quality Assurance profile who would enjoy stepping into a central HQ position and take up an important role in ensuring the high standards in pharmaceutical products?
Join the heart of Quality Assurance in a leading allergy company
ALK is a global allergy solutions company with a wide range of allergy treatments, products and services that meet the unique needs of allergy sufferers, their families and healthcare professionals. To ensure high quality of products, ALK has a well-functioning QA department at their HQ in Hoersholm.
Among other things, the QA department is responsible for QA for QC and Development & Projects. This department consists of two teams with a total of 12 people. One team is responsible for QA for QC and the other one is QA for Development & Projects. In the latter team consisting of six people they are now looking for a new experienced QA Professional with responsibility for Process Development.
Experienced and eager to take on responsibility
As QA Professional, your main responsibility is initially to act as QP delegate for Investigational Medicinal Products (IMP). You will also act as QA Professional in terms of being the expert within the process development on key projects. You will be responsible for quality assurance for development activities of products and processes within both Drug Substance and Drug Product. The job contains involvement in development projects with review and approval of CMC related documents, manufacturing documents, deviations, changes, PPQ and file-submission support.
You must be familiar with GMP regulations for biologics and allergens within EU and US and working with a risk-based approach to the development process, product and manufacturing process is an advantage.
Furthermore, the job involves maintenance of the internal quality management system and training activities.
It is expected that you hold a master’s degree within Pharmaceutical Sciences, Biochemistry or similar combined with minimum 5 years of experience from a similar position. It is required that you have great experience within Investigational Medicinal Products (IMP) regulations, packaging and release of IMP to clinical trials. You will act as QP delegate for ALK’s IMP which requires close contact to their clinical trial support team and quality oversight of their clinical packaging CMO’s. ALK has many exiting clinical studies planned which requires quick support for release of clinical trial product within tight study timelines. Interest in supplier management qualification is an advantage.
Want to know more?
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Consultant, Emine Murati on tel.: +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.
Deadline for application: As soon as possible