- 5+ yrs. of Skilled 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, PQs, 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: IT QM, Validation/Qualification, Risk management, Handling of defects/Deviations, Investigations, CAPA Handling, 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.
Additional Responsibilities
- 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
Technical and Professional Requirements
Primary skills:Domain->LifeSciences->LifeSciences - ALL
Preferred Skills
- Domain->LifeSciences->Pharma Regulations->Computer Systems Validation (CSV)