Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 month(s)
No Travel Required
Skills
GxP
CSV
SOPs
ISO
ICH
user manuals
validation protocols
Job Details
- Develop and maintain SOPs, user manuals, validation protocols, and regulatory submission documents.
- Translate complex scientific and technical concepts into clear, concise documentation.
- Collaborate with SMEs to gather and verify technical information.
- Ensure documentation complies with industry standards (GxP, ISO, ICH).
- Manage document lifecycle using electronic document management systems (EDMS).
- Author and execute validation protocols (IQ/OQ/PQ) for equipment, software, and processes.
- Perform Computer System Validation (CSV) in accordance with 21 CFR Part 11 and GAMP 5.
- Conduct risk assessments and support change control processes.
- Review and approve validation documentation and reports.
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