Develop, execute, and document test method validation protocols to ensure accuracy, precision, and reliability of testing procedures.
Lead validation activities for new or existing test methods, ensuring compliance with regulatory standards (e.g., FDA, ISO).
Review and assess the performance of test methods, providing recommendations for improvements as needed.
Perform data analysis and generate reports for test method validation studies, ensuring all required documentation is complete and compliant.
NPI Implementation:
Collaborate with cross-functional teams (R&D, manufacturing, quality, etc.) to ensure smooth implementation of test methods during the NPI process.
Assist in creating and updating validation plans, risk assessments, and process flow diagrams for new product introductions.
Develop and execute qualification protocols for new products and production processes, ensuring readiness for manufacturing.
Participate in design and development reviews to provide validation input on new products.
Ensure timely identification and resolution of issues during the NPI phase.
Compliance and Documentation:
Prepare and maintain comprehensive validation documentation, including protocols, reports, and test records.
Ensure compliance with internal SOPs, industry standards, and regulatory requirements.
Support audits and regulatory inspections by ensuring that all validation activities and documentation meet applicable guidelines.
Continuous Improvement:
Provide technical expertise and recommendations for process improvements and test method enhancements.
Stay updated on industry best practices and emerging technologies to ensure the validation process remains effective and efficient.
Requirements:
Bachelor's degree in engineering, Life Sciences, or related field.
Minimum of 4 years of experience in test method validation and/or NPI implementation in a regulated environment (medical devices, pharmaceuticals, etc.).
Proven experience in the development, execution, and documentation of test method validation protocols.
Experience with NPI processes and knowledge of associated regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820).
Technical Skills:
Strong knowledge of test method validation principles, including statistical analysis and data interpretation.
Familiarity with risk management tools (e.g., FMEA, risk assessments).
Experience with design controls, qualification protocols, and life cycle management.
Proficiency in validation-related software and tools (e.g., Minitab, JMP, Excel).
Understanding of regulatory standards such as ISO 9001, ISO 13485, and FDA requirements.
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