Job Description
**Job Purpose:**
+ 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.
+ Participate in audits and regulatory inspections.
+ Train and support personnel on ...
+ 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.
+ Participate in audits and regulatory inspections.
+ Train and support personnel on ...
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