An IT CSV Consultant is required for a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
This role offers you a chance to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus.
Excellent opportunity for an IT CSV Consultant with:
o Responsibility for validating, at a minimum new or changes to Automation systems, Enterprise Systems and Laboratory Equipment
o Coordinating and monitoring the validation phases and informing management of project progress.
o Assessing systems to determine validation and data integrity requirements.
o Developing and executes all validation project deliverables
o Generating Validation/SDLC documentation.
o Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines.
The IT CSV Consultant will require:
o BSc qualification (Degree) in a scientific, technical or engineering discipline
o 5+ years of experience working with Computer Systems for pharmaceutical/Biotech manufacturing facilities.
o Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation.
o Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
Call Kathy in LSC on 0214777 329 to discuss this IT CSV Consultant role in more detail or apply directly via this advert