- Corporate Core LIMS operational qualification- Site OQ/PQ issue and execution coordination, production roll-outs for the modules of Environmental Monitoring, Raw Materials, Packaging Materials, Semifinished/Finished Products, Stability Studies- Legacy LIMS system virtualisation validation

The assigned Project tasks consisting on:- RFI- RFP- PoC scripts - Deep dive sessions on short list solutions- Steer.co meetings- Contract negotiation

The Project consisted of two linked areas:- Setup of a unique QC baseline for common processes in chemical/pharma sites- Collect LIMS requirements through a combination of local on site visits and interviews, and multi-site SMEs workshops organized on different hosting sites

Support in Quality Assurance (including training on cGMP Chp. 6, Ch. 4, Annex 11)Responsible of:- LIMS System Management- Design and implementation of an integrated Environmental Monitoring data collection and processing system in MS Excel- Design and implementation of a non parametric decision model for Out-of-Trend in Stability Studies

Qualification of Perkin Elmer UV and CDS assessment and change from local PC systems to a Client/Server system.

Legacy LIMS system update and validation

Management of the internal Laboratory Information Management System, GMP data collection and processing, including system training and mentorship

• In charge of designing, developing and implementing business applications; • Actively participated at the interviews to system owners and final users in order to gather requirements for either software changes or new developments; • Provided field support service.