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Senior Quality Manager/ Head of QA
vor 4 Monaten
Following the dynamically growing number of registrations and corresponding market and production activity of our client, an established, growth-focused Austrian, nationally and internationally active pharmaceutical company is looking for a motivated personalty for the expansion of the Viennese HQ QA team.
Tasks
Manage the QA and release tasks and the QA team of the Group
- Operative Team Leader of the QA team and Deputy Leader of the RA/QM department
- Manage the QA tasks of the group including a.o. new SOPs and actualization of existing SOPs, documentation, quality system, GMP certification, audits and inspections of new respectively existing license production sites, ev. transfer projects, quality aspects of SW projects, and ISO 13485 certification
- Manage the QC tasks of the group including supervision of license manufacturers’ QC
activities and API purchases
- Regular release activity as operative QP according to the AMBO 2009 and the respective EU GMP regulations in terms of Batch Certification for all territories as well as all implied further QP responsibilities, (based on ISO 13485 certification) act also as the future RP for medical devices
- Improvement of the quality management system and routine processes to maintain GxP compliance
- Participation in and contribution to strategic plans and development
- Reporting to Leader of the RA/QM department
**Requirements**:
- University Degree (pharmacy or related) and valid QP certification according to - 7 AMBO 2009 (EU QP QUALIFICATION REQUIRED- PLEASE ONLY APPLY IF YOU HAVE THIS QUALIFICATION), RP (MDR) qualification is a plus
- 10-15 years’ GMP job experience in the pharmaceutical industry, ideally including experience in the development of various galenic forms of small molecules
- Experience in the respective QA, QC, and QP/release areas
- Reliable, but also self-driven, proactive, entrepreneurial, solution-oriented, flexible personality with strategic interest in the regular tasks and new projects, plans, and ideas
- Relocation to Vienna, Austria () and willingness to travel occasionally (e.g., to audits at license production sites in Europe)
- Business fluent in English (company language), other language skills (e.g., in German or Eastern European languages) are a plus
- Good MS Office user skills
**Benefits**:
- The opportunity to take over an entrepreneurial task and both operative and strategic responsibility for the quality and release areas of a dynamically growing Austrian pharmaceutical company with license production sites and sales in various European countries
- EUR 70.000,-- minimum annual gross salary, depending on qualification and experience a higher salary is negotiable
