Experience: 5+ years
Location: Remote

Required Skills :

Should have 4+ years of experience in computer system validation in the life sciences domain.

1. Strong understanding of regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11 and GAMP5.
2. Proficiency in validation lifecycle documentation and processes.
3. Proficiency in change control management.
4. Expertise in review and authoring end to end CSV deliverables.
5. Good hands-on experience in Assessments, planning, assurance activities and reporting.
6. Review and authoring of the qualification protocols.
7. Ability to work with multiple teams and handle CSV activities single handedly.
8. Strong written and verbal communication skills.
9. Ability to work independently and as part of a team.