Associate

Company Description

We are looking out for CSV consultants for one of client based out in Navi Mumbai.

Role Description

This is a contract role for an Associate, based on-site in Navi Mumbai. The Associate will handle SAP HANA computer system validation (CSV) tasks following GAMP5 guidelines, assist in project management activities, ensure 21CFR Part 11 compliance with company policies, and provide support to various departments within the organization. The role involves coordinating team efforts, creating & maintaining validation documentation, and liaising with clients to ensure smooth operations.

Qualifications

Generating

• & maintaining SAP HANA validation documentation
• Project management skills to assist in coordinating and overseeing project activities
• Compliance knowledge to ensure adherence to company policies and procedures
• Working knowledge on SAP validation, following GAMP guidelines & emsuring compliance with 21 CFR Part 11 requirement compliance.
• Experience in test script writing & script executions
• Excellent communication and interpersonal skills
• Capability of working independently and contributing to team efforts
• Previous experience in a SAP validation or similar role is an advantage
• Bachelor's degree in B.Pharma or B.Tech, or a related field