Engineer/Sr. Engineer - Validation - Malaysia
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- To plan, conduct and follow-up validation exercises in accordance to BMI Validation SOPs, such as Design Qualification , Installation Qualification ,Operation Qualification , Performance Qualification and Releasing Final Validation Report for all medical devices production's equipments and products.
- This includes to assist and review inspection procedure for In-line Test Station , to follow up on corrective actions that, were requested by Validation Team, to follow up on documentation availability at production in accordance to ISO 9001, ISO 13485, cGMP and USFDA-21 CFR Parts 820 QSR (Process Card, Machine Adjustment Card, Preventive Maintenance Program etc.), to perform visual and functional test for product whenever necessary during Operational Qualification, to document all findings, actions and results into checklist during each qualification.
- To train production personnel on the usage of documents such as Process Card and Machine Adjustment Card, to ssist QM department for performing process audit and follow up corrective actions implementation, to prepare and execute department Standard Operating Procedures, to ensure that the established validation exercise has consistently produce a result or product that meeting its predetermined specifications, to ensure that the validated process is able to demonstrate that controlling, monitoring and/or equipment are capable of operating within the parameters prescribed for the process equipment and to participate in any project which involves Risk Assessment for project, product and process where applicable.
- Plan and execute qualifications to product, process, equipments, and other as request and ensure the effectiveness.
- Provide training to relevant persons on process controls documentation (Process Card, Machine Adjustment Card, Inline Test Station, etc).
- Assists Quality Management on Audit process whenever necessary.
- Assists superior on CAPA management process, Risk management, Complaint Handling, Change Control process and other quality issues whenever required.
- Bachelor ' s Degree with 0-3 years of related working experience.
- Knowledge of ISO 13485.
- FDA 21 CFR Part 820.