Reema Aslam

Quality Assurance Associate @Sgs Nutrasource

Guelph, ON, CA

Audit Program Management: Assist in developing and maintaining the Annual Audit Schedule. Conduct QA audits, including Investigator Site, Vendor, Internal audits (Process based audits, TMF audits,study-specific audits, study start-up audits) Generate detailed audit reports and communicate findings to relevant stakeholders. Work closely with project teams/stakeholders to ensure corrective and preventive actions are implemented. Study Specific Document Review: Assist in reviewing study protocols, reports, and other study-related documents. Vendor Management: Assist in vendor management, including vendor qualification Deviation, Issue Escalation and CAPA Management: Support review of deviations and issue escalations Ensures appropriate and timely escalation and review of quality issues, including potential misconduct orissues of significant deviation with projects/products. Support review/drafting of CAPA plans Work closely with stakeholders to ensure timely implementation of CAPAs. Change Control Management: Assist with change control processes and ensure compliance with internal and external standards. Audit hosting: Assists with managing client audits/qualification visits, including preparation activities, hosting, responses toaudit/inspection reports, and follow-up on commitments made during the audit and in the audit reportresponse Controlled Document Management: Participate in the development and enhancement of QA procedures and tools. Support the development and maintenance of Cross functional controlled documents. Assist with Policy, SOP, WI, forms and templates review, preparation and issuance Training Management: Assign and review employee training compliance. Provides GDP and onboarding training to staff. Provide QA guidance to project teams and ensure adherence to regulatory requirements. Promotes GXP Compliance across the organization.