We need QA TECHNICIAN for an international pharmaceutical company based in Barcelona:
MAIN RESPONSABILITIES:
- Ellaboration of dossier corresponding parts which support Sterility Assurance Package for products with scope FDA.
- Evaluation of compliance and assurance of current requirements in terms of Regulatory Guidelines and GMP, of manufacturing processes and validation for sterile products, mainly by terminal sterilization processes.
- GMP activities of review of documentation for release.
- Support in audits & evaluation of GMP compliance requirements by suppliers.
PROJECT SCOPE:
- Main focus is on sterile generic products for FDA market.
EDUCATIONAL REQUIREMENTS:
- University Degree in Life Science.
- Minimum 3 years of experience in production/QA with sterile production products.
- Excellent level of english and editorial skills
