Overview
On Site
Full Time
Skills
Computerized System Validation
SAP
OpenText
IQ
OQ
PQ
Regulatory Compliance
GxP
Collaboration
Quality Assurance
Specification Gathering
User Guides
Technical Writing
Auditing
Documentation
Job Details
Job Description:
We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation
skills. This role is critical in ensuring compliance, validation, and
accurate documentation of enterprise applications, particularly in regulated
environments (GxP/21 CFR Part 11).
Responsibilities:
We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation
skills. This role is critical in ensuring compliance, validation, and
accurate documentation of enterprise applications, particularly in regulated
environments (GxP/21 CFR Part 11).
Responsibilities:
- Perform Computer System Validation (CSV) activities for SAP and OpenText systems.
- Develop and execute validation protocols (IQ, OQ, PQ) in line with industry regulations.
- Ensure compliance with FDA, GxP, and 21 CFR Part 11 requirements.
- Collaborate with IT, QA, and business stakeholders to gather requirements and translate them into validation deliverables. Author, review, and maintain validation documentation, technical specifications, and SOPs.
- Provide technical writing support, including preparation of user guides, technical documentation, and audit-ready records.
- Support audits and inspections by providing validation evidence and documentation.
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