Operations Quality Specialist

2 weeks ago


kannur, India beBeeQuality Full time

Job RoleTo assess and qualify manufacturers and products including pharmaceuticals, medical devices, and other activities related to document coordination, project execution, and quality assurance tasks.Key Responsibilities Evaluate plants for compliance with regulatory requirements. Verify the authenticity of ISO and other certificates with issuing bodies. Conduct site visits for desktop audits or cause-related audits as needed. Collect and assess documents required for product approval, including product questionnaires, specifications, release criteria, and stability studies. Review and approve product documentation in SharePoint. Verify CE and other certifications for authenticity with certificate-issuing bodies. Engage in discussions with manufacturers regarding product queries. Prepare assessments for product approval and product datasheets. Assist in reviewing pharmaceuticals and medical devices for layout approval and review. Evaluate temperature files from shipments reaching customers. Create item codes and plant codes in AX. Manage QD mailboxes, ECM requests, and support functions related to quality. Support the implementation of quality management systems and compliance with global and site-specific procedures. Collaborate with corporate QA to define, revise, and implement quality management systems and standard operating procedures. Assess warehouse temperature files and provide justification or risk assessments. Participate in implementing projects that involve quality functions. Provide segment-specific solutions for quality-related matters.



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