Computerized System Validation (CSV) Specialist

About IVY Works

IVY Works was founded by a team of professionals with significant expertise in the Life Sciences sector. Our mission is to be a comprehensive service provider, offering consulting and support for compliance, validation, Computerized System Validation (CSV), IT Infrastructure Qualification, and IT Solutions tailored for clients in the life sciences industry. We aim to improve current operations by delivering the necessary knowledge and experience for managing and controlling related services.

Role and Responsibilities

The primary responsibilities for this role involve the development of validation documentation and providing support for computerized systems utilized within GLP, GMP, and GCP regulated environments, specifically for Manufacturing and Laboratory Systems. This includes creating and executing validation protocols and comprehensive validation documentation packages. These packages will cover validation plans, specifications, test protocols, and standard operating procedures. The systems involved span Process Automation, Laboratory Automation, Laboratory Instrument Applications, Enterprise IT Applications, and IT Infrastructure.

Preferred Candidate Profile

Ideal candidates will possess prior experience or exposure to Computerized System Validation (CSV). A strong understanding of regulatory guidelines such as 21 CFR Part 11 and EU Annex 11, along with familiarity with GAMP 5, is essential. Excellent technical writing and communication skills are mandatory. Candidates must also be willing to travel as required by the role.

Additional Information

This is a full-time, onsite position located in Pune, India.