Job summary

Responsible on designing and developing protocols to be fulfilled so that the products under manufactured meet policies, procedures, regulatory requirements. Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements of company, industry, countries' legislations manufacturing standards.

• Validation Evaluation for new or modified process/equipment system/facility

• Process characterization study

• Identify key process variables that would affect product quality

• Identify equipment critical part/feature that would affect process parameter and product quality

• Hazard Analysis/risk assessment and other process study

• Develop VMP for whole processes of production by product with necessary justifications based on above assessment/study

• Design and develop validation protocol

• Design validation study features, such as sampling, testing, or analytical methodologies.

• Direct validation activities, such as protocol creation or testing.

• Prepare validation protocols for new or modified manufacturing processes, systems, or equipment.

• Study product characteristics or customer requirements to determine validation objectives and standards.

• Conduct validation or qualification tests based on internal protocols and/or external standards.

• Assist in training operators or other staff on validation protocols.

• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.

• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.

• Identify deviations from established product or process standards and provide recommendations for resolving deviations.

• Manage deviations and changes in order to guarantee that these are well documented and corrective actions are taken and followed up upon.

• Draw samples of raw materials, or intermediate and finished products for validation testing.

• Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.

• Procure or devise automated validation test stations or other test fixtures and equipment.

• Align facility validation strategies and policies with actual outcomes

• Continuous competence development in Validation and maintenance of validation documentation and database

• Communicate with regulatory agencies regarding compliance documentation or validation results.

• Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or technologies.

• Prepare, maintain, or review validation and compliance documentation.

• Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.

Qualification

• Bachelor's degree in engineering or science.

• Above 4 years relative work experience in QC/QA or similar in the medical device industry

• Excellent problem resolution, judgment, and decision-making skills required with thorough working knowledge of QC tools, methods and practices.

• Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable standards.

• Good command of English in communication

• Good command of MS office software application

Working Conditions

• Working Days: Monday to Friday

• Working Hours: 08:30 – 17:30

• Uniform: Not required

• Company Transportation: Not provided

• Canteen: Available (note: no food vendor on-site)

Benefits

• Fixed Bonus

• Variable Bonus

• Group Insurance

• Provident Fund