Qualified Person

vor 2 Wochen

Wien, Österreich Talentor Austria GmbH Vollzeit

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 ROLE
- Act 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 REQUIREMENTS
- University 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 OFFERS
- An 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 € 65.000 (excluding bonus). Overpayment is possible and depends on your qualifications and work experience.

ARE YOU INTERESTED?

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