Achieving Regulatory Excellence

12 hours ago


mangalore, India beBeeCompliance Full time

Product Compliance SpecialistThe Product Compliance Specialist is responsible for evaluating and qualifying suppliers, including pharmaceutical manufacturers and medical device producers, as well as coordinating documents, managing projects, and overseeing quality control activities.Evaluate manufacturing sites to ensure compliance with regulatory standards.Verify authenticity of ISO and other certificates from issuing bodies.Conduct on-site audits at supplier locations as needed.Key Responsibilities:Collect and assess documentation required for product approval, including questionnaires, specifications, release criteria, and stability studies.Review and approve product documentation in SharePoint.Authenticate CE and other certificates with the issuing body.Engage in discussions with suppliers regarding product queries.Prepare assessment reports for product approval and product datasheets.Requirements:Bachelor's degree or higher in a scientific field, such as pharmacy or chemistry.4-6 years of experience in QA/QC, Production, or Regulatory departments of pharmaceutical or medical device companies.Familiarity with quality systems, GMP-related issues, SOPs, stability testing, and manufacturing processes.



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