Quality Assurance (QA) Manager to Intervacc AB
At Intervacc, we believe it is urgent to develop better vaccines to prevent the spread of the infectious diseases of today and tomorrow. We believe in the vison of One Health and that in order to create a healthier world we need to look at the system as a whole to fight existing and new infectious diseases in animals as well as in humans. We need to combat zoonotic diseases and we need to slow down the development of antibiotic resistant bacteria. We are dedicated to developing safe, effective and practical vaccines within animal health, and to bring these vaccines to the global market. This is our passion and our mission.
We have an exciting new opportunity for a Quality Assurance (QA) Manager who will be responsible for quality management of external manufacturing and supply of Intervacc’s products. The Quality Manager will have a central role in oversight and management of external manufacturing and analytical activities from a quality perspective.
Intervacc AB has its HQ in Stockholm Sweden and is listed on the Swedish Nasdaq First North Growth Market. The position is full time and we welcome your application today!
This role requires experience of development and validation of manufacturing and/or analytical processes, working in a GMP environment within a pharmaceutical or biotechnology company. You will be responsible for reviewing documentation and batch records to identify problems, assisting with investigations, and supporting change controls, together with the quality departments of Intervacc’s suppliers.
Duties and responsibilities include:
• Quality oversight of external GMP manufacturing activities
• Management of supplier audits and approval
• Quality Agreements
• Oversight of customer complaints and recalls
• Oversight of Change Management and Corrective and Preventive Actions
• Refine, maintain and implement the on-site quality system for GXP
SKILLS AND COMPETENCIES
The suitable candidate has the following qualifications:
• Formal academic training to degree level in a science-related subject
• >5 years quality management experience
• Experience of working in a GXP (GMP or GDP) environment is essential for this role
• Experience from authoring, reviewing and management of GXP-critical documents such as standard operating procedures, and instructions
• Fulfilment of the qualifications and experience to be named as the GDP Responsible Person and / or Qualified Person for GMP is merited
The successful candidate for this position will be someone who:
• Takes ownership and accountability to drive continuous improvement of the quality system
• Has a good eye for detail and a thorough approach to work
• Is a proactive, flexible, motivated and ambitious team player
• Is adaptable to change
If you are ready to bring your expertise in quality management, we are ready to offer you an excellent career opportunity at an innovative company with an exciting journey ahead!
Intervacc is a Swedish biotechnology company specialized in vaccine development within Animal Health and has its own sales and distribution business in Scandinavia and the Baltics. We develop veterinary vaccines based on fusions of recombinant proteins together with the world leading scientific expertise from the Karolinska Institute and the Swedish University of Agricultural Sciences. The Intervacc share (STO: IVACC) is listed on the NASDAQ First North Growth Market. Our headquarter is in Stockholm, Sweden and we have local offices in Copenhagen (DK), Riga (LV) and New Market (UK). You can find more information about Intervacc at http://www.intervacc.com