Executive - Compliance
B. Braun
- Pulau Pinang
- Permanent
- Full-time
- To be responsible and accountable for all aspects regarding compliance, complaints and CAPS, to ensure proper and smooth operations of the plant.
- To evaluate and monitor on plant's procedure /SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation of the assigned plant.
- To propose and to implement Corrective Action needed to align the compliance of plant practice and documentation.
- To ensure GMP compliance to regulatory requirements such as FDA/TUV.
- To coordinate necessary activites within the plant before, during and after the audits , internal and external.
- To coordinate all corrective actions needed after audits and to ensure timely response and implementation of corrective actions.
- To coordinate all CAPAs activites within the department and to ensure that al CAPAs are closed timely.
- To coordinate and monitor market complaints and to ensure timely feedfack/closure.
- To propose and implement necessary corrective actions related to market complaints, conduct internal audits within own division from time to time and to monitor/update on CAPA/market complaints during plant's regular meetings.
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
- Bachelor Degree in Engineering / Science or equivalent
- 1-2 years working experiences in quality /compliance /regulatory affair.
- Knowledge of Quality Management Systems related to Medical Devices, eg.: ISO13485, MDSAP, 21 CFR Part 820, GMP.
- Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
- Quality auditing experience or exposure to quality audit environment.
- Plan and execute necessary activities within the plant before, during and after the audits, internal and external.
- Evaluate and monitor on plant's procedure /SOP/documentation/specification/records and to ensure they are in compliance with daily practice/operation.
- Preferably in experience in driving continuous improvement in Quality / Compliance project with strong communication, coordination and follow-up skills.
- Preferably good statistical analysis skills and familiarity with tools (Pie chart, Histogram, Power BI etc)
- Be accountable.
- Communicate effectively.
- Execute efficiently.