ABF Pharmaceutical Services GmbH

ABF Pharmaceutical Services GmbH

Job Overview

ABF Pharmaceutical Services GmbH

ABF Pharmaceutical Services GmbH 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 the approved pharmaceuticals. ABF is a member of the GBA Group Pharma, one of the Europe’s largest and most experienced service groups in the pharmaceutical and biotech sector. As a unique “one- stop solution” the company supports the entire process of drug development and commercialization. GBA Group Pharma generates annual sales of around 50 million euros.

We are looking for support in our QP Team

QUALIFIED PERSON (QP)

YOUR 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 the 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 the importation
  • Pre-approval of batch records
  • Approval of batch records
  • Batch releases according EU-guidelines

YOUR QUALIFICATIONS:

  • QP qualification according AMBO 2009 §7 and Directives 2001/83/EC, 2001/20/EC and 2003/94/EC Master’s degree or PhD in chemistry, biology, pharmacy or a related discipline
  • At least 3 years’ experience working in Quality Assurance or in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)
  • Thorough understanding of quality systems and (c)GM regulations
  • Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms
  • Ability to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs, IMPDs and clinical trial authorizations
  • Interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs
  • Ability to prioritize and multitasking in a stressful environment
  • Ability to read, understand, speak and write technically and legibly in English
  • Experience in conducting audits

OUR OFFER

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

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 for applicants who are interested in bringing new values, working in an international environment and are looking for new challenges.

Please provide your application (CV, letter of application) per e-mail to andreas.nechansky@abf-pharma.com.

Share this job

“By expats for expats”

AustrianCareer.at is the first expat friendly job platform in Austria where you can find all English speaking job openings.

office@austriancareer.at