Lead or co-lead quality audits to analyze and ensure that the basic processes of our plants and suppliers are effective. Evaluate suppliers and our quality systems to ensure full compliance to ELC and all applicable regulatory requirements. This position is a member of the Global Quality Assurance Audit team.
60% - Perform audit of suppliers. Audit activities include, defining the audit objective, defining audit requirements scheduling audits with suppliers, conduction opening & closing meetings and performing audits as the lead or co-auditor for Components, Raw Material, Third Party Manufactures (TPM), Estee Lauder manufacturing sites and third party testing laboratories. Ensure that audits are conducted according to EL policy and requirements, that every audit has a timely audit report issued, and that corrective action/preventative action (CAPA) plans are identified for every audit.
15% - Update the audit tracking database with audit schedule, audit report and audit observations. Rank suppliers according to EL risk profile. Participate in collecting and reporting quality matrix.
10% - Collaborate with of members of the QA organization and other functions at ELC in continuous improvement of the audit program.
15% Other duties as assigned may include management and processing of OTC complaints and processing new supplier audit request.
Bachelor's degree 60% Travel Minimum 5 years experience auditing external suppliers. Good knowledge of applicable regulations and guidance documents, able to apply critical thinking skills to evaluate requirements. Knowledge of global cGMP standards. Working knowledge of 21 CFR 210, 211, Health Canada GMP’s, ISO 22716, EFfCI and ICH Q7. Computer literate with good working knowledge of Microsoft products. (SAP knowledge an added advantage).