Qualified Person

vor 2 Monaten

Wien, Österreich Valneva Vollzeit

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.

**Responsibilities**:
We are currently looking for a motivated** Qualified Person - QP (M/F/d) **to join our **Quality Assurance **Department in **Vienna**. Your Key responsibilities will involve working with vaccine products, overseeing technology transfers, and ensuring strict adherence to Good Distribution and Manufacturing Practices. In detail you will be working on tasks such as:

- Act as a **Qualified Person** (QP) for two of our products **IXIARO and IXCHIQ**, ensuring compliance with **EU GMP regulations** (Annex 16) for **Batch Certification** across all markets, including all associated QP responsibilities
- Act as a **Responsible Person** (RP) for the Austrian Territory according to the Austrian “Arzneimittelbetriebsordnung” (AMBO) and EU GDP guideline
- Provide quality oversight for **Third-Party Logistics Providers** (3PLs) and internal QA systems to maintain compliance and quality standards
- Authorize product release through 3PLs to ensure timely availability of commercial products in Austria
- Collaborate with **Commercial Operations and Supply Chain Management** on all quality-related matters to support operational needs
- Participate in local and global Quality Harmonization/Consolidation Projects regarding **Product Certification** and other QP-related topics
- Participate in supplier audits and regulatory inspections, with potential requalification as **Lead Auditor** per VIE-SOP-0149 **Quality Audits**:

- Actively support further development of the Quality Assurance Department by providing professional experience related to the performance of Quality Systems
- Actively support Quality Assurance activities related to authority and 3rd party inspections
- Update job knowledge with all regulatory requirements and development in quality management, participating in educational opportunities relating to the work of Valneva

**Requirements**:

- University **degree in life sciences** with substantial GMP experience in the **Pharma or Biotech industry**:

- At least **3-4 years of experience in a GMP-regulated environment**, with a strong foundation in **GDP**-regulated practices
- **Certified **by a Competent Authority to serve as a **Qualified Person (QP) per EU legal requirements**:

- Qualified to act as a **Responsible Person (RP)** in accordance with EU regulations
- Proficient in technology transfer processes and GMP manufacturing operations
- Proven experience in working with **commercial products** and compliance with Good Distribution Practices
- Leadership capabilities as a plus and strong **project management skills**:

- Strong analytical skills, able to structure and interpret complex information effectively
- Skilled in drafting clear, well-argued documents
- Excellent communication skills and social competence, with a **proactive, team-oriented mindset**:

- **Customer-focused **approach and adept in conflict management
- Fluency in both written and spoken English

**Benefits**
- Open, appreciative company culture with innovative spirit and attractive assignments
- International surrounding with flat hierarchies
- Good team spirit in a strong and highly motivated team
- Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, LinkedIn Learning etc.
- Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 90.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience._

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