Overview
On Site
Full Time
Skills
HVAC
GMP
Risk Assessment
Gap Analysis
Quality Assurance
Documentation
IQ
OQ
PQ
Regulatory Compliance
Acceptance Testing
Job Details
Responsibilities:
- Develop commissioning and qualification protocols for HVAC, purified water systems, clean utilities, and other critical utilities according to regulatory requirements (GMP, FDA, etc.).
- Execute commissioning and qualification activities for utilities systems, ensuring adherence to project schedules and quality standards.
- Conduct risk assessments, impact assessments, and gap analyses related to utilities systems.
- Coordinate with cross-functional teams including engineering, quality assurance, operations, and validation to ensure successful project outcomes.
- Generate and review commissioning and qualification documentation (IQ/OQ/PQ protocols, reports, SOPs, etc.) in compliance with regulatory guidelines.
- Participate in FAT/SAT (Factory Acceptance Testing/Site Acceptance Testing) activities for utilities equipment and systems.
- Troubleshoot utilities systems and equipment issues during commissioning and qualification phases.
- Support validation activities, including process validation and cleaning validation, as needed.
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