Job Description
Job Description
- Responsible for overall management of Process Validation Program, Stability Program and PFMEA program.
- Coordinate, monitor and execute the Process Validation Program and Stability Program for Bard Sdn.
- Ensure compliance to BD Corporate procedure, Division procedure, and Bard Sdn. Bhd. procedure.
- Act as a validation independent reviewer and technical independent reviewer for process validation protocol and report. Review process validation data generated and perform statistical analysis where appropriate.
- Serve as change control coordinator for the site change project.
- Perform gap analysis against the BD Corporate Procedure, Divisional Operating Procedures and Corporate Policy and update local procedures accordingly.
- Maintain and update, when necessary, all BOPs for Process Validation, PFMEA, Software Validation Program, Finished Product Testing and Stability Program.
- Act as proto...