OVERVIEW
- To assist manager to establish and maintain the procedures for monitoring and control of process parameters or validated processes to ensure that specified requirements continue to meet.
DUTIES AND RESPONSIBILITIES
- To coordinating and leading the process validation to ensure that, a process consistently produces a result or product meeting its pre-determined specifications.
- Prepared validation protocol to state how validation will be conducted, including test parameters, product characteristic, production equipment, and decision points on what constitutes acceptable test result.
- Coordinate and/or perform validation process, which cover installation and operation qualification, process performance qualification, and product performance qualification.
- Ensure that the process and monitoring equipment's are calibrated at the beginning of the validation study, checked at the end of the study to establish confidence in the validation of process.
- Compile, review and analyse the results from the validation.
- Prepare final validation report for the management approval.
- Review, evaluate and perform re-validation when necessary.
- Check, identify and report on any deviations in procedure against actual practice in Validation.
- Conduct Internal Quality Audits as per HSB-SOP-036 Internal Audits covering all elements in the ISO 9001, ISO 13485, CMDR, Medical Device Directives (MDD 93/42/EEC), US FDA Quality System Regulation, Japanese Good Manufacturing Practices etc
- Provide training, guidance and coaching to subordinates (if any).
REQUIREMENTS
- Bachelor Degree in Science or any related field or Diploma in Science with at least 1 year working experience.
- Minimum 1 year of working experience with similar roles and responsibilities preferred.
- Good communication skills in both verbal and written, clear and easy to understand and include listening skills.
- Work location : Sepang, Selangor.
