Identifies and sets appropriate quality standards and parameters for products.
Monitor and Reporting to the Top management on the performance of the quality management system and any need for improvement at planned intervals including continuous improvement program.
Promoting of awareness regarding customers, statutory and regulatory requirements throughout the organization.
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· Lead and manage the QA department to ensure robust implementation of Quality Management Systems (QMS), including Change Control, Product Quality Review, and Risk Management.
· Serve as the Authorized Person for final product release, ensuring compliance with GMP and timely delivery aligned with production schedules.
· Oversee and verify that all required validations, QC testing, batch record reviews, deviation management, and regulatory requirements are met prior to batch release.
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• Support compliance with the requirements of ISO 9001, IATF 16949, ISO 14001, ISO 45001, customer-specific requirements, and applicable statutory and regulatory requirements.
• Assist in following up on corrective and preventive actions (CAPA).
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Perform daily operations, problem solving, and continuous improvements in the Laboratory.
Supervise LAB analysts and technicians during testing and that will also include equipment troubleshooting, equipment failure handling and investigation.
Review analytical test results (inclusive of both raw materials and product) and monitor trends to detect early anomaly to prevent an Out-of-Specification situation.
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