Qualified Person – Quality Assurance


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Siehe Firmendetails

Kontakt: Gwen Kerforn
Telefon: +43 1 890 63 60

About HOOKIPA:

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.

This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA’s platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.

HOOKIPA’s pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead.

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@hookipapharma.com

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

 


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