Site Name: Vietnam - Ho Chi Minh City Posted Date: Oct 3 2024 As a Quality Control (QC) Supervisor, you will oversee the implementation and monitoring of quality systems to ensure GSP warehouse operations meet regulatory and GSK standards. You will collaborate with cross-functional teams to manage compliance, support audits, and drive continuous improvement, ensuring safe and effective handling and distribution of pharmaceutical products. Job Purpose: • The position will ensure quality operations and systems in the GSP warehouses are in place and in use and compliance with the rules and regulations of the regulatory agencies (WHO GSP, GDP and part of GMP) and GSK QMS. • Provide support to the QA Manager to ensure product quality compliance through E2E product flow. • Provide support to the QA Manager to achieve and sustain the state of compliance to secure product quality to customers. • Provide support quality and cross-functional team to perform and ensure the CAPA from GMP, GSP audits close on time. • Perform the management of monitoring program to assure activities of all sections are in compliance with applicable GSP, GDP, part of GMP and GSK policies and LSOPs. • Generates and secure records to comply with regulatory requirements, (GSP, GDP and part of GMP and GSK QMS. • Ensure completion of validation, re-qualification and periodic validation review for GSP warehouses and computer systems. Key Responsibilities: • Coordinate and collaborate cross-functional team to perform gap analysis and local response to regulations (WHO GSP, GDP and part of GMP) and GSK QMS. Revise and update LSOPs to fulfil the gaps accordingly including organizing the training for implementation. • To maintain QMS training matrix and deliver training plan for cross-functional team related to GSP warehouse operations. • Ensure document control and data management for GSP operations comply with local and GSK QMS requirement. o Generate and update controlled documents (e.g., procedures, forms, reports) as local requirement and GSK QMS, to ensure compliance with applicable quality processes/system o Provides support for the implementation and/or maintenance of a documentation structure, LSOPs and related local processes, enabling common Quality Systems and documents to be used within affiliate, including maintenance of accuracy of quality records, version updates and effectivity, periodic record review, obsoleting and archiving. o Provide support for document control via Veeva Quality Docs (VQD) and other computer systems. o Ensure change control, deviation, Root cause analysis documents related to GSP warehouse operations are verified and documented. • To perform quality operations through E2E product flow: o Regular compliance check to ensure right first time of inbound and outbound batch release. o Review and verify the results from operation activities (storage condition, monitoring data, Pest control, device calibration) o Verify returned goods activities to ensure process in use and effectiveness. o Track and monitor returned complaint samples to ensure they are appropriately reported, recorded and resolved on a timely basis. • Perform and monitor management of monitoring program to assure activities of all sections are in compliance with applicable GSP, GDP, part of GMP and GSK policies and LSOPs. • Participate and support audits, follow up post-audit if required • Perform quality trend analysis related to product complaint, deviation, CAPA, change control. • Monitor and ensure GMP and GSP CAPAs closure on time. • Check, review and ensure effectiveness and in use of GMP and GSP CAPA. • Monitor and ensure third-party CAPAs closure on time. • Support QA Manager to perform validation, re-qualification and periodic validation review for warehouses and computer systems. • Internal/External Customer & Partners Satisfaction o Build network with cross functions in order to build a transparent and consistent working environment within the company. o Assist GSK Vietnam build quality culture and quality event. • Training/ skill enhancing o Participate in training course in My-learning/conducted by local Quality team/Region Quality team/CERPs/SAP/Function LSOPs. o Ensure quality induction training take place. • Key Deliverables (Success Measures & KPI’s): o Maintain GSP Certification and Compliance for operations. o Maintain GMP Audit Certification and Compliance for operations. o QMS Compliance o GSP Warehouse Operations o LSOPs In place and In use o E2E Batch release. o CAPA effectiveness Key Requirements: • Pharmaceutical degree. • At least 7 years at minimum of professional experience in GSP, GDP and GMP and Quality management system. • Professional experience in MNC for pharmaceutical • Good communication & inter-personal skills. Ability to support and challenge at the same time senior leaders. • English: fluent oral & written communication. Preferred Qualifications: • Stakeholder management (internal and external): Strong leadership, mentoring, and interpersonal skills with the ability to interact with personnel at all levels. • Strong organizational and project execution skills, with to ability to effectively manage multiple tasks, priorities, and deadlines in a fast-paced environment. • Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits • Knowledge on effective quality documentation systems. • Ability to deliver clear communications and good working relationships with peers and management • Problem-solving skills within a structured process • Good team player – works well in cross-functional teams • Works with a spirit of continuous improvement, creatively open to new ideas and methods *LI-GSK Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. 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