Quality Assurance Auditor II, GMP

December 20, 2024

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KCR

Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs

Description

• Assume responsibility for quality assurance activities to support GMP Pharmacy audits. • Perform contracted, routine and complex internal audits according to client expectations and/or the company's SOPs. • Function as a lead auditor on an audit team. • Ensure planning, conduct, reporting, responses and follow up actions are managed according to the company's internal procedures. • Review and assess non-conformities and other pertinent GMP documentation as per recognized GMP standards of EMEA/FDA. • Facilitate client audits and regulatory inspections.

Requirements

• Life science degree at Bachelor or Masters level from an accredited institution. • 2+ years of previous experience working as a GMP Auditor. • Fluency in English. • Excellent communication skills. • Strong personality who functions well either as a team member or sole contributor. • Technically competent in all aspects of auditing and GMP manufacture. • Experience of facilitating/hosting audits and Inspections. • A self-starter with drive and enthusiasm.

Benefits

• Various annual leave entitlements; • A range of health insurance offerings to suit you and your family’s needs; • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead; • Global Employee Assistance Program; • Life assurance; • Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.

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