CSV Specialist
Flexible & Integrated Technical Services, LLC
- Añasco, PR
- Permanent
- Full-time
- Bachelor's Degree in Life Sciences or Engineering and at least three (3) years of previous exposure in Validation activities within the Pharmaceutical or Medical Devices industry.
- Bilingual, Spanish and English (good communications)
- Shift: Administrative & according to business needs
- Experience in:
- Validation Life Cycle (CSV)
- Automation & Control Systems
- GMP & GDP
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
- Ensure design specification, qualification, and change control documentation is current, controlled, and approved to meet quality, information security, and safety requirements.
- Build and complete validation plans, system test scripts, protocols, and reports, while maintaining appropriate traceability of records
- Ensure timely, thorough, and complete execution of all protocols, meeting FDA requirements.
- Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
- Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
- Ensures complete and thorough investigation of all product failures and deviations associated with validation sampling and testing.