Qualified Person – Quality Assurance

Date posted: 08. July 2022
Location: Vienna

Position Summary

The Quality Assurance department at HOOKIPA has an open Manager position for a Qualified Person.As part of the growing department the incumbent will focus on activities for release of our investigational medicinal products. Furthermore, the successful candidate will support the department in daily business.

Main Responsibilities
  • Batch record review
  • Issuance of Certificates of Compliance, QP certificates and QP confirmations
  • Evaluation and processing of complaints, deviations, OOS and change control
  • Creation and improvement of quality systems and SOPs
  • Review and approval of master batch records, specifications, CoAs and other GMP relevant documents
  • Conduction of risk assessments and involvement in qualification and validation processes
  • Creation, review and approval of quality-relevant documentation
  • Preparation, participation in and follow-up of self-inspections, audits and authority inspections

Qualifications

  • Fully eligible to act as Qualified Person according to the requirements as defined in §7 of AMBO 2009
  • At least 3 years experience in the Quality Assurance area of a GMP-regulated pharmaceutical company preferably in the field of ATMPs and/or viral vectors
  • Hands-on knowledge of EU GMP regulation
  • 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 3.643,- 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 are interested in this challenging position, please send your CV including a cover letter summarizing your qualification and experiences to: talent(at)hookipapharma.com

For more information on HOOKIPA please visit www.hookipapharma.com

Apply Now!