CSA and CSV practitioner

Hiring,

Greetings from Modern Agile Technologies

Position: CSA and CSV practitioner

Location: Remote

Type:        Contract

Skills & Experience Required:

·        Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain

·        Familiarity with QMS processes including deviation management, CAPA, and change control.

·        Strong command of CSA (Computer Software Assurance) principles

·        Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+).

·        Proven ability to write and manage validation deliverables including Test Strategy (Risk-based testing, CSA),\ HPLC software