QA Operations Specialist (GMP Review & Compliance)

Renowned pharmaceutical company

Job Description

• Review and evaluation of GMP-relevant documents, records, and quality systems
• Support in the release or blocking of GMP materials and components
• Participation in quality-relevant projects and compliance initiatives
• Ensuring compliance with GMP guidelines and internal quality standards
• Support in the further development of quality processes and quality systems
• Assistance in the creation, review, and maintenance of SOPs and quality documentation
• Analysis and handling of quality-related issues in the operational environment
• Close collaboration with interdisciplinary teams within production, quality, and supply chain
• Ensuring high data integrity as well as correct GMP documentation

Profile

• Completed degree (Bachelor or higher) in Pharmacy, Biology, Chemistry, Biotechnology, Life Sciences, or a comparable field
• Language requirements: fluent in German and English
• Alternatively, a technical or scientific education with relevant professional experience in the GMP environment
• Initial professional experience in Quality Assurance, Quality Operations, or GMP documentation review
• Experience in a regulated pharmaceutical or biotech environment
• Good knowledge of GMP guidelines and quality standards
• Experience with electronic quality systems (e.g. SAP, TrackWise, Veeva, MES or comparable systems) is an advantage
• Strong affinity for document review, compliance, and quality processes

The Offer

Interested in the next career step?
I look forward to your application.