SQ Auditor Pakistan

Job Description

Standort: Pakistan - Sindh - Karachi Datum: Aug 12 2022 Job Purpose: Ensure that suppliers of production materials / components and critical service providers within assigned areas of responsibility for conducting audits/ assessment meet applicable Regulatory Authorities and GSK requirements. Provides the management oversight ensuring that supplier quality audit activities are carried out in accordance with GSK standards & procedures. Education, Experience & Skills: Post graduate in Pharmacy & Chemistry or Master?s degree from a reputable institute 3-5 years of relevant experience in Pharma Industry. Stakeholder Management Audit Quality Risk Assessment Key Responsibilities: ? Responsible for defining which suppliers/supplier types, within role scope, may be considered for virtual / hyb+i+1 /remote assessment and which require on-site audits. ? Responsible for defining appropriate audit standards for supplier types within role scope and ensuring adequate alignment of the GSK audit standards with the GSK Quality Management System (QMS). ? Responsible for performing GMP/Quality System assessments/audits of assigned suppliers within role scope; making a risk based recommendation on the approval ? status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines. ? Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines. ? Responsible for confirming proposals regarding the continued use of suppliers with marginal compliance. ? Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines. ? Responsible for maintenance of ?auditee? (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided. ? Responsible for supporting change controls from assigned suppliers, as needed, as per the current procedures. ? Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified. ? Responsible for authoring, participating, as applicable, in the development of internal Supplier Quality processes to ensure compliance with the GSK QMS (Quality Management System). ? Responsible for completion of all relevant training curriculums within the stipulated time frame. ? Responsible for following the relevant SQ related authorized procedures. ? Routinely interfaces with site Quality/Procurement, Procurement Commodity teams, SQ Ops and GSK suppliers ? a two way communication regarding supplier audit results and impact on materials, components and services delivered to the site, supplier audit results, CAPA plans, STPs, etc. Kontaktinformationen: Sie knnen sich fr diese Position online bewerben. Klicken Sie dazu auf die Schaltflche Jetzt bewerben . Wichtiger Hinweis fr Arbeitsvermittlungsunternehmen/?agenturen GSK akzeptiert keine Empfehlungen von Arbeitsvermittlungsunternehmen und/oder Arbeitsvermittlungsagenturen fr die auf dieser Website ausgeschriebenen freien Stellen. Alle Arbeitsvermittlungsunternehmen/?agenturen mssen sich an die Abteilung fr gewerbliche und allgemeine Beschaffung/Personalabteilung von GSK wenden, um die schriftliche Einwilligung einzuholen, bevor sie GSK Bewerber empfehlen. Der Erhalt einer schriftlichen Einwilligung ist Voraussetzung fr jegliche Vereinbarung (sowohl mndlich als auch schriftlich) zwischen dem Arbeitsvermittlungsunternehmen/der Arbeitsvermittlungsagentur und GSK. Falls diese Genehmigung nicht erteilt wurde, wird davon ausgegangen, dass smtliche Handlungen des Arbeitsvermittlungsunternehmens/der Arbeitsvermittlungsagentur ohne die Zustimmung von GSK oder ohne eine vertragliche Vereinbarung mit GSK unternommen wurden. Aus diesem Grund haftet GSK nicht fr irgendwelche Gebhren, die aus solchen Handlungen oder aus Empfehlungen von Arbeitsvermittlungsunternehmen/?agenturen fr die auf dieser Website ausgeschriebenen freien Stellen entstehen.

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