Address
Form of work Responsibilities:
- Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
- Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
- Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
- May also investigate and trouble-shoot problems which occur and determine solutions.
- Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
- Maintains all documentation pertaining to validation.
- Will assist in developing procedures and/or protocols.
- Coordinates contract personnel through completion of assignments.
- Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
- Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems.
