Back to jobsBachelor’s degree in Computer Science, Information Technology, Engineering, or related field.
3-5 years experience in IT Computer System Validation or regulated IT/Quality environments
Solid understanding of GxP, GAMP 5, Data Integrity (ALCOA+), and 21 CFR Part 11/Annex 11
Experience in writing technical documentation and executing testing activities.
Strong communication and problem-solving skills.
Ability to collaborate effectively with cross-functional and cross‑regional teams.
Strong documentation and communication skills
Strong organizational skills and the ability to work effectively in a high-paced, fast-changing environment, results-oriented
Ability to manage and prioritize tasks effectively, especially in the context of projects
Ability to work independently with minimal supervision, while being able to work with a diverse team with varying skill level
Strong documentation skills to maintain accurate records of changes, policies and procedures.
Languages: Portuguese and English (written and spoken)
Experience with ERP, LIMS, QMS, or other GxP computerized systems.
Familiarity with risk based and critical thinking approaches aligned with CSA principles.
Previous audit or inspection exposure.
Familiarity with AI-related standards applicable to GxP environments.
