Corporate Quality Audit, External Audit (pharma)

Job Responsibilities • Execute Corporate and supplier audits such as first GMP, routine, Targeted Technical Assessment (TTA) and For-Cause audits in accordance with Apotex's SOPs and current GMP regulations • Adopt the best practices of Excellence in Partnership to develop and sustain effective relationships with Apotex sites, suppliers, contractors, and business partners • Perform Due Diligence audits of potential new Apotex suppliers, generate reports and provide recommendations pertinent to suitability and sustainability of the quality and compliance of new suppliers. Propose remediation plans to mitigate risks that could be impeding the future stability of Apotex supply chain • Liaise with Apotex Enterprise sites to evaluate the leading indicators such as QPIs prior to conducting site audits to ensure high risk areas are included as part of the site audit scope. Communicate potential non-compliance aspects of the audit outcome with the applicable site leadership team and escalate to Apotex Escalation Committee (AEC) as appropriate • Research and compile all available supplier quality/procurement data such as complaints, investigations/deviations, recalls in Apotex systems (SAP, QMS TW, LIMS, etc.) and external systems (e.g. Health Canada, FDA, MHRA websites) to ensure high risk areas are included as part of the audit scope. • Perform Risk Profiling of Apotex suppliers for Predictive Analytics to determine the audit frequencies based on the risks • Compile precise, accurate and chronologically factual audit reports within the allotted time to enable meaningful review and approval of the audit reports • Communicate the identified deficiencies and compliance risks to appropriate business stakeholders such as Global Active Pharmaceutical Ingredients (GAPI), External Manufacturing Quality (EMQ), Supplier Quality (SQ), Business Development (BD), Apotex Site Heads and Global Supply & Technical Operations (GSTO)