Quality Compliance Auditor
Job Description
Responsibility : * Manage on-site / desktop audits and evaluate Regional supplier and Third Party Manufacturers \u00A0 * Create, maintain and execute Audit Schedules in Trackwise Audit system and ensure its compliance * Review Quality Questi
Responsibility : Manage on-site / desktop audits and evaluate Regional supplier and Third Party Manufacturers u00A0 Create, maintain and execute Audit Schedules in Trackwise Audit system and ensure its compliance Review Quality Questionnaires returned by the Suppliers/TPMs and resolves any issues. Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs audits Participate in internal audits of Manufacturing site & affiliates auditing programme. Review & verify CAPA for observations arising from Regulatory Agency audits & Internal audit observations, at the manufacturing site for its completeness and implementation. Manage Affiliate Audit program, Support the regional management in execution of various assigned tasks Experience & Skills: Performing Audits in Drug products u2013 Sterile & Non-sterile, API, Biosimilar products etc. Excellent communication skills & report writing skills in English language Risk analysis , CAPA Development Computer skills for Microsoft Presentation / Word Document /Excel & PDF 10+ years of experience in Pharma Auditing in an MNC / Large Pharmaceutical Company.
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Job Detail
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Job IdJD2920117
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear