Key Responsibilities
Engage in all validation activities, including:
* Facilities and utilities validation
* Validation life cycle management
* Execution of validation processes
* Technical documentation preparation
* GAP analysis and risk assessments
Deliver validation documentation, including:
* User Requirement Specifications (URS)
* Design Qualification (DQ)
* Failure Mode and Effects Analysis (FMEA)
* Risk assessments
* Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
* Protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
* Prepare and execute validation documents for equipment and systems
* Write reports on completed validation activities
* Identify efficiencies in the validation approach
* Stay updated on regulatory changes affecting validation
Perform Quality Systems activities, including:
* Document management
* Change control
* Non-conformities and CAPAs management
* Write or revise engineering-related procedures
* Support the engineering team with validation and maintenance programs
* Perform additional duties as required