CSV Consultant

Responsibilities

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.

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

• Computer Systems Validation (CSV)

Educational Requirements

Bachelor of Engineering