Beschreibung: |
Position Summary
The QC Specialist manages program-specific stability studies, oversees stability related activities and ensures timely execution at external contract laboratories. Monitoring and analyzing data as well as summarizing the results and conlusion in a report are also part of this function.
Main Responsibilities
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Management of Stability Studies for Drug Products, Drug Substances, and Intermediates stored under several conditions (long-term, accelerated studies, In-Use stability studies)
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Generation of Stability Protocols and Reports
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Ensuring timely testing of stability samples within the analytical test window at external contract laboratories
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Data monitoring and trending as well as statistical analysis
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Support evaluation of shipping and handling excursions
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Ownership of OOS/OOE events, deviations and changes with regards to stability
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Act as subject matter expert for stability relevant sections for regulartoy submissions
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Contribute to continuous improvements and process optimization of HOOKIPA’s Quality Management System
Qualifications
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University degree in natural sciences or equivalent technical discipline required, ideally in Biochemistry, Biotechnology or Pharmacy
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Strong experience in Quality Control and/or Quality Assurance
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Profound biotechnological and/or pharmaceutical understanding
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Particular knowledge of stability studies with gene therapy products is a strong plus
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Hands-on knowledge of EU GMP regulation
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Experience with quality systems (OOS investigations, deviations, CAPAs, and change controls)
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Competence in Microsoft Office Tools
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Fluent in English, both spoken and written
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Valid EU working permit
What we offer
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Strong team with dedicated and passionate employees
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State of the art infrastructure
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An excellent working atmosphere
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Opportunities for personal development
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Employee benefits such as health screening, public transportation card, Sodexo pass
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Working in a multinational and multicultural environment
We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 2.754,- (Specialist) 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
Contact:
If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com
For more information on HOOKIPA please visit www.hookipapharma.com
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