Assurance Compliance Expert

1 week ago


nashik, India beBeeQuality Full time

Quality Assurance SpecialistThis role involves the assessment and pre-qualification of manufacturers and products, including pharmaceuticals and medical devices. The job requires coordination of documents, execution of segment projects, and QA-related tasks.Create item codes and plant codes in enterprise software systems.Handle quality document mailboxes, electronic content management requests, and provide support with quality functions.Implement quality management systems to ensure compliance with global procedures and site-specific protocols.Detailed Job RequirementsThe Quality Assurance Specialist will be responsible for the following activities:Perform desktop evaluations of facilities as required.Verify authenticity of ISO and other certificates with issuing authorities.Visit manufacturers for document audits or cause audits when necessary.Collect and assess product documentation needed for approval, including questionnaires, specifications, release criteria, and stability studies.Review and approve product documentation in a collaborative platform.Verify authenticity of CE and other certificates with issuing authorities.Engage in discussions and explanations with manufacturers regarding product queries.Prepare assessments for product approval and create product datasheets.Assist in the review of pharmaceuticals and medical devices related to layout approval and review.Evaluate temperature files from shipments reaching customers.



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