CSV Specialist
For Computer System Validation and Software services in the Manufacturing area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s Degree in Life Sciences or Engineering and previous exposure in Computer System Validation activities within the regulated industry.
- Bilingual, Spanish, and English.
- Shift: Administrative & according to business needs
- Experience in:
- Computer System Validation life cycle.
- Implementation of a Software revision on an existing application.
- GMP environment.
- Protocol execution and final report generation
The Personality Part:
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?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Write, execute and maintain on a timely basis CSV protocols.
- 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, batch failures and deviations associated with validation sampling and testing.
- Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
.png){kind=small}