Overview
On Site
Full Time
Skills
Computer Science
Electronic Engineering
Information Systems
Test Scripts
Collaboration
IQ
OQ
PQ
Testing
Reliability Engineering
GMP
ISO 9000
Auditing
Documentation
Regulatory Compliance
Research and Development
Quality Assurance
Manufacturing
Job Details
Roles & Responsibilities:
- t least a bachelor's degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required.
- Develop and execute validation plans, protocols, and test scripts for equipment, processes, and systems.
- Collaborate with cross-functional teams to establish validation strategies.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Conduct testing and calibration to ensure equipment/system reliability and compliance.
- Document validation activities, including deviations and resolutions.
- nalyse data and trends to recommend improvements to validated systems.
- Maintain and update validation lifecycle documentation as processes and equipment evolve.
- Ensure all validation activities comply with applicable regulations (FDA, GMP, ISO, etc.).
- Participate in audits and inspections, providing documentation and expertise as needed.
- Train staff on validation processes and compliance requirements.
- Work closely with R&D, Quality Assurance, and Manufacturing teams to support validation initiatives.
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