
Posted 3 months ago
QA qualification engineer
AI Summary
A QA qualification engineer reviews and approves IQ/OQ/PQ protocols and reports, ensures regulatory compliance, and provides technical guidance to project teams in pharma, biotech, or medtech environments.
About this role
agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.
As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.
You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.
Tasks
- Reviewing and approving IQOQPQ protocols and reports for a wide range of QC/Production equipments and utilities
- Ensuring compliance with relevant regulations (e.g., GMP, USP, Ph. Eur.).
- Providing technical guidance and support to project teams.
- Participating in equipment qualification meetings and reviews
- Maintaining accurate records and documentation.
- Supporting internal and external audits.
- Staying abreast of relevant industry standards and regulations.
Requirements
- Master's degree in Biotechnology or a related field
- 3 years minimum experience in QA for qualification for pharma, biotech or medtech companies
- Fluent in English
- Swiss or EU nationality
Skills
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