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Job Summary
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To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Quality Engineer (Validation) located in Senai, Johor .
What a typical day looks like:
- Well verse in GMP procedures and validation requirements and experience at gathering technical information from vendors and scientific literature
- Serves as the validation coordinator on selected project teams.
- Ensures validation including protocols and reports compliance to site requirements and all applicable ISO 13485, FDA Quality System Regulation, cGMP requirements and any other applicable regulations.
- Develop validation master plan and validation protocols (IQ/OQ/PQ), write test scripts and lead process validation activities for various manufacturing processes
- Assists in the review and validation of process changes including protocols and report for completeness, accuracy and compliance to the site requirements, FDA Quality System Regulation, and ISO 13485 Standard.
- Interface with all medical customers to provide Flex Medical and Site compliance on validation overview including equipment qualification, change control.
- Assists to ensure a GMP compliance culture, and auditing program including corrective action process.
- Assess change controls, facility work orders and equipment risk assessments to ensure compliant/validate state of all GMP equipment and systems
- Ensures that validation activities, protocol, report, and execution are being carried out in compliance to site and regulatory requirements.
- Perform deviation investigations and help to implement CAPA and re-validation as necessary
- Possesses a Degree in related discipline or equivalent experience.
- Minimum 5 years of working experience in the related field is required
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Job Category
Quality
Required Skills:
Optional Skills:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).