QA Qualification & Validation Specialist

ARTO; Wien; On-site; EUR 65,000 - 90,000; Full time

Job summary

ARTO in Vienna, Austria is seeking a QA Qualification & Validation Specialist (GMP) with German and English language skills. You will oversee QA review and approval of qualification documentation for a new production line, ensuring GMP compliance and data integrity across equipment and processes.

The role focuses on end-to-end qualification activities, including IQ/OQ/PQ, risk assessments and change controls, with collaboration across Engineering, Manufacturing and Quality Assurance teams.

Qualifications

• Minimum 4 years of experience in pharmaceutical GMP qualification and validation.
• Experience with QA review and approval of qualification and validation documentation.
• Strong knowledge of equipment qualification, GMP risk assessments and the qualification lifecycle.

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.

Skills

QA oversight

Documentation review

GMP qualification

Validation lifecycle

Communication

Education

Degree in a relevant scientific/engineering field

Tools

GAMP 5

FAT/SAT

IQ/OQ/PQ protocols

Job description

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.