CSV Consultant

CSV Consultant

• Primary skills:Domain->LifeSciences->LifeSciences - ALL • Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability • Good knowledge on software configuration management systems • Awareness of latest technologies and Industry trends • Logical thinking and problem solving skills along with an ability to collaborate • Understanding of the financial processes for various types of projects and the various pricing models available • Ability to assess the current processes, identify improvement areas and suggest the technology solutions • One or two industry domain knowledge • Client Interfacing skills • Project and Team management Key components of the responsibilities are as mentioned below but not limited to:  5+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.  Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.  Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.  Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.  Stakeholder management and good executor with required communication.  Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation/Qualification o Risk management. o Handling of defects/Deviations o Investigations o CAPA Handling o Test Management & Compliance  Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.  Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.