Freelance - Responsible Person - Austria

Vor 4 Tagen

Wien, Österreich ProPharma Group Vollzeit

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

**Job Description**:
In this position, you will act as the Responsible Person for the Austrian site and ensure all regulations are achieved accordingly to the guidelines for the WDA. In addition, you will maintain an overview of the supply chain activities; review and approve change requests, deviation reports, CAPA’s as well as liaising with Regulatory authorities. You will also have the opportunity to provide strategic advice, support QA activities in general; support Technical Operations teams and prepare for any Healthcare authority inspections. Lastly, ideally you will also act as the Business Manager (Gewerberechtlicher Geschäftsführer) and assume associated tasks with this function

**Qualifications**:

- A University degree in Science/Engineering is required, preferably MSc in Pharmacy or similar.
- 5-8 years’ experience working in QA in a GMP/ GDP environment, with demonstrated experience working as an RP
- Experience in functioning as RP on WDA-license.
- Adequate knowledge of classification of recalls process including recall
classifications
- Experience with local Austrian authority inspections and MIA/WDA-licenses.
- Fluent in English and German
- Must be eligible to work in Austria
- Can work remotely and travel to Vienna when required

Additional Information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed

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