PHARMACEUTICAL VALIDATION ENGINEERS

Pharmaceutical Validation Engineers

GCP and 21 CFR Part 11 standards and related regulatory guidelines;

CSV SDLC, Quality System Implementation, Auditing, Change Management;

GMP, GLP, GCP,GDP and GAMP;

ISO13485, ISO 14971, 21 CFR Parts 11, 820, 210/211;

SPC, DOE, Advanced Collaborative Environment (ACE);

EDMS (QUMAS), FMEA (Failure Mode and Effects Analysis);

IQ, OQ , PQ Protocols; Labware LIMS, Watson LIMS, SQL LIMS; Nugenesis, Waters applications; Trackwise and Documentum workflows; SAS Clinical trials;

Oracle Clinical trials; Epic testers

Our Valuable Clients

Product Development

People Connect: This product creates value for your organization by investing in HR of the future. Streamline your process and optimize your multi-generation resources through easy-to-use, push-button solutions. This transforms the paper to digital in HR ways as single unit which caters the Human capital management, analytics, employee self-service, social connectivity etc... Readmore

Our implementation partners are with the Amazon AWS(E3) for cloud enabled services to provide low cost solutions to the clients from small scale to large scale organizations Readmore