Engineer II, QA
Singapore - 7 Gul CircleUpdate time: November 21,2019
Job Description
Job Responsibilities:
- Review and approves validation protocols for product and process changes.
- Review and approve revision changes to DOPs, manufacturing process, components, software and labeling.
- Ensure failure investigations are performed and well documented for non-conforming materials and products.
- Establish and maintain database to track root cause, disposition, and cost for non-conforming material.
- Review customer complaints and analyze data for trends.
- Identify quality issues through data and trend analysis, work with relevant functions on corrective and preventive actions.
- Work with management to devise and implement quality strategies and policies.
- Conduct internal/external audits to assure compliance to quality and regulatory requirements.
- Supervise technician in the inspection, batch record review and release of products.
- Provide guidance and training to other employees and QA Technicians as required.
Job Requirements:
- Engineering Degree with minimum 2 years of QA Compliance experience, preferably in pharmaceutical / biotech industries.
- Possess working knowledge of ISO13485 and QSR.
- Excellent verbal and written communication skills required.
- Proficient in the use of quality tools (e.g. Trend, regression charts) to present and articulate identified issues.
- Self-motivated, results oriented with strong planning and scheduling skills.
- Applies knowledge to principles and concepts which contributes to the development and enhancement of company processes.
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