- Teva Pharmaceuticals (Edison, NJ)
- …parameters related to installation, operation, and performance of related facility, utilities, computer systems , or equipment. + Analyze complex datasets to ... Utility, and Equipment systems , with minimal supervision. + Develop and review Validation / Qualification protocols and reports that challenge the critical… more
- Bristol Myers Squibb (Summit, NJ)
- …+ Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + ... standards. + Works closely with and enters data into the site CMMS system . + Ensures all calibration, PM, and performance verification records are filed… more
- Innovation Foods LLC (Millville, NJ)
- …Plant Director and leadership team to improve Quality & Food Safety systems in response to organizational performance, changing regulations, and customer demands. ... product to ensure customer specifications are met. Oversee Quality Assurance systems to satisfy internal and customer requirements to include process evaluation… more
- Insight Global (Edison, NJ)
- …(incident/priority/resolution) - Familiar with GxP systems , Computer System Validation and in the support of FDA regulated systems and business ... the day with reliability, review on incidents open (which systems need to be connected internally) - follow up...in Process Mapping and Design preferred. Experience in MLL systems such as, MES, LIMS, Historian, Lab Systems… more
- Hovione (East Windsor, NJ)
- …to: Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), ... and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary...and procedures in place - Ensure the change management system is applied correctly and confirm that prior to… more
- Integra LifeSciences (Plainsboro, NJ)
- …shall participate in the development, review and/or approval of various Quality System Documentation to ensure that the development, manufacture and distribution of ... and approve quality documents requiring QA oversight (eg, IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier… more