To strengthen our Business Unit Pharma Team at our site in Vienna we are hiring as early as possible the following:

Qualified Person (m/f/d)

(Vollzeit oder Teilzeit)


We Offer:

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surroundings with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Home Office possibility
  • New office building with bright, modern offices
  • Free fruits and coffee
  • Free parking
  • Reachable by public transportation

Main Duties and Responsibilities:

  • Experience in evaluation of Dossiers Module 3 and IMPD’s  
  • Advice for customers regarding documentation and approvals for clinical trials according EU-guidelines
  • Establishments of QM-documents (Quality Technical Agreement, QP to QP agreement, etc.)
  • Evaluation of third party audits
  • On-site and remote audits globally
  • Control of documents for clinical trials (CTA, EC)
  • Assessment of batch records  
  • Generation of QP-declarations 
  • Preparation of batch releases prior to importation
  • Pre-approval and final approval of batch records
  • Batch releases according EU-guidelines

Skills and Education:

  • Experience in business development for more than a year
  • Strong knowledge and practice of pharmaceutical analysis/GMP.
  • GMP basic knowledge, basic knowledge of logistics, invoicing and customs matters
  • Excellent knowledge of MS office
  • Good english language skills (Level B2 according to CEFR, spoken and written) or willingness for education
  • Good communication skills, regulations
  • Creative and solution-oriented thinking
  • Willingness to work flexible hours in accordance of customers need.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 70.000,– gross per year based on full-time employment. Our salaries are market oriented and adapted based on your qualifications and experience.

We are looking forward receiving your complete appliciation.

Please be informed that we can only accept applications via our hompage. Any applications via e-mail or by post can’t be processed.

The GBA Group is one of the leading laboratory and consulting service providers in Europe. Our core competencies are in the fields of environmental, food and pharmaceutical analysis.

On behalf of the pharmaceutical industry, GBA Group Pharma provides analytical and chemical services such as method development and validation, batch testing and stability testing for active ingredients, excipients and finished drugs.

ABF Pharmaceutical Services is a Viennese company founded in 2004, specializing in all aspects of international clinical trials, including project management, manufacturing, logistics and EU approval of investigational medicinal products, as well as import, storage and logistics for approved pharmaceuticals. ABF is member of GBA Group Pharma, one of Europe's largest and most experienced service groups in the pharmaceutical and biotech sector. As a unique "onestop solution" the company supports the entire process of drug development and commercialization. GBA Group Pharma generates annual sales of around 50 million euros.

ABF Pharmaceutical Services GmbH
Mrs. Rebekka Depner
Brunner Strasse 63/18-19
1230 Vienna
Austria

 

 

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