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