HOOKIPA Pharma Inc. is a clinical stage biopharmaceutical company developing a new class of immunotherapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.
The Quality Management department at HOOKIPA has an open QA Specialist position, who will actively contribute to the quality oversight of the manufacture and testing of HOOKIPA’s GMP products, in order to ensure their quality, safety, efficacy and stability.
As part of the growing department the incumbent will mainly focus on the maintenance of the evolved Quality Systems according to the ICH/EU/AMBO requirements. The ideal candidate has a hands-on mentality, is analytically skilled and problem-solving oriented as well as detail-oriented, driven, independent, and able to respond quickly to evolving needs. The ability to work in a fast-paced environment and professionalism are all essential assets for this role.
The Quality Assurance Specialist will contribute to put the defined processes into practice with the possibility to generate and maintain quality documents and to ensure their compliance. Implementation into day-to-day practice and constant evaluation of the applied processes will be tools for the Specialist to help to continuously improve the established Quality Systems.
- Execute and administrate specific parts of the Pharmaceutical Quality System and implement/monitor performance measures
- Contribute to handling of deviations, change controls, OOS results and generation of risk assessments
- Perform batch record reviews and other QA groundwork for batch release
- Support maintenance of the supplier management system and perform quality oversight of CMOs, CLOs and CROs
- Generate and distribute relevant quality documents
- Maintain document management system, in GMP and non-GMP areas
- Contribute to the GMP training program and self-inspection procedure
- Participate in preparation, hosting and post-processing of authority inspections
Qualifications & Skills:
- First experience (at least 2 years) in pharmaceutical industry preferably in the field of Quality
- Hands-on knowledge of EU GMP regulation (however, deeper knowledge can be acquired during initial training and on-the-job training)
- Education in technical and natural/life sciences (Chemie HTL, MTA, university up to MSc)
- Fluent in English, both spoken and written
- Competence in Microsoft Office Tools
What we offer:
· - Strong team with dedicated and passionate employees
· - State of the art infrastructure
· - An excellent working atmosphere
· - Opportunities for personal development
· - Working in a multinational and multicultural environment
· - Help with shaping the Quality System of a growing biopharmaceutical company
We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 2.487,- based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible
If you (m/f) are interested in this challenging position, please send your CV including a cover letter summarizing your qualification and experiences to: firstname.lastname@example.org
For more information on HOOKIPA please visit www.hookipapharma.com