QA Qualification & Validation Specialist (GMP)
- German-speaking
Department:
Quality Assurance | Qualification & Validation
Seniority Level:
Mid-Senior / Senior Specialist
Language Requirement: Fluent German (C1 or higher) and very good English
The Opportunity We are looking to connect with experienced
QA Qualification & Validation Specialists
for opportunities within GMP-regulated pharmaceutical manufacturing in Vienna, Austria.
The role focuses on
QA oversight, review and approval of qualification documentation for a new production line build , ensuring that pharmaceutical equipment, manufacturing systems and validation activities meet GMP and regulatory requirements.
This opportunity is particularly relevant to experienced QA Specialists, Qualification Engineers and Validation Professionals with strong technical experience and a background in GMP compliance.
Key Responsibilities
Review, assess and approve
end-to-end
GMP qualification documentation, including
URS, risk assessments, requirements traceability matrices, FAT/SAT, IQ/OQ/PQ protocols and qualification reports .
Provide QA oversight of equipment and facility qualification activities associated with pharmaceutical engineering and expansion projects.
Support quality oversight during commissioning, process validation and cleaning validation activities.
Review qualification of computerised manufacturing equipment and systems in accordance with
GAMP 5, EU GMP and data integrity requirements .
Manage and assess deviations, change controls, CAPAs and GMP documentation.
Support the development, review and improvement of validation procedures and SOPs.
Collaborate closely with Engineering, Manufacturing, Quality Control, Project Management and external equipment suppliers.
Candidate Requirements
Degree in a relevant scientific or technical discipline, such as Biotechnology, Chemistry, Pharmacy, Pharmaceutical Sciences or Engineering.
Minimum 4 years of experience in pharmaceutical GMP qualification and validation.
Demonstrable experience in the
QA review and approval of qualification and validation documentation .
Strong knowledge of equipment qualification, GMP risk assessments and the qualification lifecycle.
Experience with computerised equipment qualification and
GAMP 5 .
Working knowledge of
EU GMP, Annex 15, Annex 11 and 21 CFR Part 11 .
Experience managing deviations, CAPAs and change controls.
Fluent German (C1 or higher) and very good English — essential.
Strong communication skills, attention to detail and a structured, quality-focused approach.
Why Apply? An opportunity to contribute to GMP qualification and validation activities within a dynamic pharmaceutical manufacturing environment in Vienna, working closely with Engineering, Manufacturing and Quality Assurance teams.
If you have a strong background in
GMP qualification, QA documentation approval and validation compliance , we would be interested in hearing from you.
#J-18808-Ljbffr
QA Qualification & Validation Specialist in Wien Arbeitgeber: ARTO
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und unterstützenden Umfeld zu arbeiten, das auf die Entwicklung Ihrer Fähigkeiten und Karriere ausgerichtet ist. Unsere Unternehmenskultur fördert Teamarbeit und Innovation, während wir gleichzeitig sicherstellen, dass Sie Zugang zu umfassenden Schulungs- und Weiterbildungsmöglichkeiten haben. Durch die zentrale Lage unseres Büros in Europa profitieren Sie von einer hervorragenden Anbindung und einem inspirierenden Arbeitsumfeld, das den Austausch mit internationalen Kollegen erleichtert.
