Primary skills:Domain->LifeSciences->LifeSciences - ALL
Key components of the responsibilities are as mentioned below but not limited to: 5+ yrs. of Professional experience and robust 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.
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