GMP QA Qualification & Validation Specialist (German)

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

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.