Location
kulim
Job Type
Full-time
Posted
May 29, 2026
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. Bhd. to ensure compliance to BD Corporate procedure, Division procedure and Bard Sdn. Bhd. procedure.
- Be a validation independent reviewer and technical independent reviewer for process validation protocol & report. Review process validation data generated and performed statistical analysis where appropriate.
- Be a 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.
- Be the protocol origina...