Vaisesika
Website:
vaisesikaconsulting.com
Job details:
Job Title : Computer System Validation Consultant with JD Edwards Knowledge
Experience: 8+ years
Location : Remote
Notice : Immediate
Responsibilities:
- Should have 8+ years of experience in computer system validation in the life sciences domain.
- Knowledge in JD Edwards
- Strong understanding of regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11 and GAMP5.
- Proficiency in validation lifecycle documentation and processes.
- Proficiency in change control management.
- Expertise in review and authoring end to end CSV deliverables.
- Good hands-on experience in Assessments, planning, assurance activities and reporting.
- Review and authoring of the qualification protocols.
- Ability to work with multiple teams and handle CSV activities single handedly.
- Strong written and verbal communication skills.
Ability to work independently and as part of a team.
Click on Apply to know more.