Define the UAT strategy, approach, entry/exit criteria and sign-off framework for CoMP, aligned to the approved BRD/HLD and overall project delivery and go-live milestones.
Responsible for identifying, analysing OOC lots, Defect Pareto, defect trend and characterization data to determine the source of defect and drive for yield improvement.
Bachelor’s degree in sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
Lead supplier qualification activities for new and/or existing suppliers, support NPD/NPI projects through leading suppliers’ Design For Manufacturing (DFM) review, PFMEA, Control Plan and Quality Agreement approval per requirements.
Develop and manage calibration schedules to ensure all IMTEs remain accurate, reliable, and compliant with applicable standards and regulatory requirements.
Partner with Supply Chain Engineering, Product Development, Planning and GSA to ensure reliable, high-quality components supply is available for manufacturing.
Assist the SEA T&L Risk Leader in executing quality and risk key priorities and strategy, and deliver high-impact initiatives and special projects from concept to rollout.
Identify and address process inefficiencies, operational bottlenecks, and service gaps, delivering measurable improvements in productivity, quality, cost, and customer experience.
Serve as the PQE representative for assembly and test operations, ensuring timely reporting, escalation, disposition, in regards of driving resolution on product quality issues, while compliance with Quality Management System (QMS) requirements.
Local: Supervise a team of API Quality Operations specialists to maintain AbbVie Quality Systems that are in place for API Manufacturing Operations in accordance to AbbVie Policies and cGMP. Monitors that Site Operations comply with AbbVie Policies and cGMP. Ensure team support of routine business operations support 24/7. Provide quality oversight for API Warehouse, QC, API Manufacturing, Engineering and IT. Responsible for change management and batch record review and release. Ensure high-quality execution and NPI has no impact to routine operations.
The Hub Marketing & Sales lead for PQP APAC Region will be responsible for defining and executing the regional growth strategy, developing the opportunity pipeline, coordinating country sales teams and factories, and ensuring effective customer and market coverage. The role will drive early engagement with key customers, consultants and partners, support opportunity qualification and tender strategy, and coordinate competitive positioning, pricing and value propositions. It will also oversee order forecasting, sales performance and market intelligence, facilitate the introduction of new solutions, and align regional priorities with the global PQP business strategy, while maintaining strong governance throughout the sales process and supporting the achievement of profitable growth, market-share and customer-satisfaction objectives.