Sound knowledge of validation principles (GAMP 5, 21 CFR Part 11, Annex 11). Familiarity with QMS systems, SDLC methodologies (Agile/Waterfall), and documentationstandards. Strong analytical and technical writing skills. Ability to interpret regulatory guidelines and apply them practically. Attention to detail, compliance-focused, and good organizational skills.experience4
Sound knowledge of validation principles (GAMP 5, 21 CFR Part 11, Annex 11). Familiarity with QMS systems, SDLC methodologies (Agile/Waterfall), and documentationstandards. Strong analytical and technical writing skills. Ability to interpret regulatory guidelines and apply them practically. Attention to detail, compliance-focused, and good organizational skills.experience4