A. Validation Activities
1. Ensures compliance with the appropriate regulations, such as 21 CFR 210 and 211 and CGMP regulations and guidelines.
2. Prepares validation and compliance documents, including those related to system procurement, audit, performance, compliance evaluation, and validation such as:
§ Qualification Protocols
§ Risk/Impact Assessment
§ User Requirements Specification
§ Functional Specification
§ Configuration Specifications
§ Validation Plan
§ Validation Reports
§ Change Controls
3. Provide validation project management support administering validation contractors in aspects related with: quality and schedule.
4. May assists or participates in system design, specification development, design review and commissioning / decommissioning activities.
5. Execute the qualification/validation protocols.
6. Assesses deviations and recommends corrective/preventive actions as necessary in compliance with current regulations and site requirements.
7. Evaluates proposed validation changes and determines qualification/validation requirements in order to ensure that appropriate measures are taken during the change implementation and that adequate testing is developed.
8. Develops and implements improvements to the Qualification/Validation activities to simplify validation execution documentation.
9. Revise Site Validation Master Plan to ensure it remains updated and to incorporate validation decisions.
10.Performs Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) for incoming equipment, if necessary.
11.Interact on validation activities of cross functional teams that include technical functions such as IT, Technical Services and Engineering, Business Process Owners, and Quality.
12.Procures training needed (internal/external) for personal development and the proper execution of validation/qualification activities.