Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
Works closely with global/local QC stakeholders to develop and endorse the following: Analytical transfer plan, validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global and Belgium QC departments on test method innovation/ evaluation to support the project team in facility design / modification specifically for QC operations.
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Lead/support site investigations, CAPAs and change controls. Drive improvement and standardization across the 3 value streams to achieve manufacturing excellence and compliance with current quality and EHS&S standards.
Lead/support site investigation, CAPA and change controls and drive improvement.
Participate in audit preparation and conduct audits in designated areas; support investigation arising from audit findings and closure of audit CAPAs.
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Partner with market teams to build an efficient, cost-effective, and responsive supply chain that continuously improves service to patients and customers.
Lead, coach, and develop MSC teams by setting clear objectives, enabling execution, and supporting talent development and succession planning.
Build strong cross-functional relationships with Market GMs and Leadership Teams, including Commercial, Finance, Compliance, Quality, Regulatory, and Legal, to align supply chain delivery with business priorities.
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Deliver high-quality scientific discussions based on the latest CVMD clinical guidelines, treatment algorithms, pathophysiology, and real-world evidence.
Ensure accurate, balanced, and compliant communication of GSK product benefits, safety profiles, and data.
Support medical education initiatives, advisory boards, and scientific meetings involving HCPs and KOLs.
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Deliver high-quality scientific discussions based on the latest CVMD clinical guidelines, treatment algorithms, pathophysiology, and real-world evidence.
Ensure accurate, balanced, and compliant communication of GSK product benefits, safety profiles, and data.
Support medical education initiatives, advisory boards, and scientific meetings involving HCPs and KOLs.
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Deliver high-quality scientific discussions based on the latest CVMD clinical guidelines, treatment algorithms, pathophysiology, and real-world evidence.
Ensure accurate, balanced, and compliant communication of GSK product benefits, safety profiles, and data.
Support medical education initiatives, advisory boards, and scientific meetings involving HCPs and KOLs.
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Develops and execute solutions to address performance gaps for assigned accounts. Proposes activities to enhance performance and competitivity for GSK portfolio within assigned accounts.
Establish and cultivate effective commercial relationships for listing of GSK products, co-ownership of strategic plans.
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Develops and execute solutions to address performance gaps for assigned accounts. Proposes activities to enhance performance and competitivity for GSK portfolio within assigned accounts.
Establish and cultivate effective commercial relationships for listing of GSK products, co-ownership of strategic plans.
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Develop, review and approve all relevant manufacturing documents in accordance to site procedures.
Support the generation of the capital expenditure (CAPEX) proposal list for budgeting. Work closely with the Technical Operations Team to establish windows for New Production Introduction (NPI) and capital projects implementation.
Generate operating budget for own section and manage expenditure to ensure achievement of operational targets and drive cost reduction initiatives.
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Data Lifecycle Management: Ensure thorough, complete and accurate documentation of all laboratory procedures and data, including standard operating procedures, workinstructions, protocols, reports, laboratory notebooks, technical memos, raw data and risk assessments. Maintain compliance with GMP and GLP requirements ensuring data traceability and easy retrieval.
Champion for Laboratory Safety and Sustainability: Support environmental health, safety and sustainability activities for the laboratory. Ensure a safe laboratory working environment and inspection readiness of the laboratory through regular safety GEMBA(s) and risk assessments for all analytical activities carried out.
Acquire knowledge on Environmental Health and Safety (EHS), Good Manufacturing Practices (GMP), Good Documentation Practice (GDP), Good Laboratory Practices (GLP) and data integrity (DI)/ ALCOA principles, with application of this knowledge as an Analytical Scientist in training.
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Develops and execute solutions to address performance gaps for assigned accounts. Proposes activities to enhance performance and competitivity for GSK portfolio within assigned accounts.
Establish and cultivate effective commercial relationships for listing of GSK products, co-ownership of strategic plans.
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Perform Life-Cycle Management of all registered products in Malaysia & Brunei such as PI/PIL Update, Artwork Changes, CMC Changes, Change of Sites, New Indications & Dosages Variations, and all other changes that affect the registered information within Regulatory Authorities in Malaysia & Brunei.
To be the custodian for all matters pertaining to the registered products including archiving and retention of the product files.
To create and approve artworks in Artwork Management System.
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