Qualified Person / Responsible Person (f/m/x)

Farkas Kiss Endre legjobb állása Talentor Austria GmbH

bernadette.arnoldner@talentor.com;Markus.Gross@talentor.com;barbara.ulman@talentor.com;alexandra.thurnher@talentor.com;birgit.wandrak@talentor.com;office.austria@talentor.com;christine.leitner@talentor.com;thomas.zembacher@talentor.com;elke.gutzelnig@talentor.com;martina.tik@talentor.com;nina.schwartz@talentor.com;ayyuece.oeztuerk@talentor.com;nina.sattlegger@talentor.com;julia.gremel@talentor.com;cara.otahal@talentor.com;pernille.stein-engvoll@talentor.com;matthias.dietrich@talentor.com;vanesa.brahaj@talentor.com;katharina.gittsovich@talentor.com

Bewerbung fur Head of Technical (Facility) Management (w/m/x) - Technische Betriebsführung in der Forschung

Levél szövege

Lieber Talentor Austria GmbH!

Ich möchte mich bei Ihrem Unternehmen als Qualified Person / Responsible Person (f/m/x) bewerben. 
Ich bin ein Fullstack-Entwickler, bei dem ich meine 10-jährige Erfahrung mit verschiedenen Technologien einsetzen kann.

Ich habe meinen Lebenslauf an diese E-Mail angehängt.

Wir freuen uns darauf, von Ihnen zu hören!


Endre Farkas Kiss "Sodika"
Java and PHP Fullstack Developer, Nudist, Vlogger

https://www.linkedin.com/in/farkas-kiss-63bb9210a
https://sodika.org

Álláshirdetés szövege

Our client, Valneva, is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical needs. The company is looking for a new colleague in addition to the existing QP. In this role, you will directly report to the Director of Quality Operations and work closely with CMOs and external partners. Qualified Person / Responsible Person (f/m/x) Location: Vienna YOUR FUTURE ROLEAct as Product QP according to the Austrian "Arzneimittelbetriebsordnung" (AMBO) and respective EU GMP regulations (Annex 16) in terms of Batch Certification for all territories, including all deduced responsibilities of a Qualified Person Act as RP for the Austrian Territory according to the Austrian "Arzneimittelbetriebsordnung" (AMBO) and EU GDP guideline Oversee quality of Third-Party Logistics Providers (3PLs) and internal QA systems Ensure timely availability of commercial products in the Austrian Territory by authorization to sell via 3PL Support Commercial Operations and Supply Chain Management in all quality-related matters as required Participate and contribute to Supplier Audits and Authority Inspections Participate in local and global Quality Harmonization / Consolidation Projects regarding Product Certification and other QP-related topics Actively support further development of the Quality Assurance Department by providing professional experience related to the performance of Quality Systems JOB REQUIREMENTSUniversity Degree with relevant GMP job experience (minimum 5 years) in the business (Pharma- and / or Biotech Industry is an asset) Approval, permission, and certification by Competent Authority to act as a Qualified Person according to legal EU requirements as well as job experience as certifying QP for commercial products Fulfills requirements to act as a Responsible Person according to legal EU requirements Thorough knowledge of GMP regulations and guidelines (e.g., AMBO, Eudralex Vol. 4, 21 CFR Part 210/211) Excellent interpersonal skills Effective conflict management skills Team player with a proactive and structured way of working Resilient character: able to work under pressure and ensure a timely outcome Willingness to travel Business fluent in English OUR CLIENT OFFERSAn open, appreciative company culture with an innovative spirit International surroundings with flat hierarchies in an existing team with a positive and ambitious working atmosphere Able to see "the big picture" within a fast-paced and meaningful environment Wide range of benefits like flextime, performance-related bonus, lunch vouchers, childcare center ("Kindergarten"), company events This position's compensation starts at a gross annual salary of EUR 65.000 (excluding bonus). Overpayment is possible and depends on your qualifications and work experience. ARE YOU INTERESTED?We are looking forward to receiving your application (English CV & cover letter incl. salary expectations) over the application-dashboard. Our responsible consultant will contact you immediately after receipt. We kindly ask you to support us in handling your application according to the GDPR regulation more effectively and refrain from applying via e-mail. Jetzt bewerben