Job Description
Job Purpose:
Key Responsibilities:
- Plan, execute, and document qualification and validation activities to ensure equipment, systems, utilities, and processes comply with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and execute validation protocols (IQ/OQ/PQ) for equipment, systems, and processes.
- Author, review, and approve validation documentation including protocols, reports, and SOPs.
- Perform risk assessments and gap analyses on systems, processes, or equipment.
- Coordinate validation activities with cross-functional teams (engineering, manufacturing, quality, etc.).
- Ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines.
- Support change control processes and evaluate the impact of proposed changes on validation.
- Maintain validation master plans and schedules for ongoing compliance...
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