Egypt Quality Lead At Takeda
Job DescriptionQuality Management System
Deploy Takeda global quality management system across Takeda Egypt GxP functions including regulatory affairs, PV, Medical affairs
Develop and maintain local quality management system compliance to the global quality standards and procedures through performing gap assessment which includes but not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.
Report on quality function KPIs and metrics and its inputs in quality council for management review.
Develop and execute Annual Country Quality Plan at the LOC. This will include the following:
Implementation of the risk management program. Establish and maintain the local risk register. Engage the key LOC stakeholders to proactively identify GMP/quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the LOC.
Follow up on quality requirements for new product launches and ensures risk mitigation plans are fulfilled.
Perform cross functional self-assessment programs to evaluate compliance with product quality systems & processes in LOC, and to identify improvement opportunities.
Manage product -related complaints on the company’s quality systems on time and follow up on timely implementation of CAPAs where required at the LOC, and verify CAPA effectiveness
Manage quality events including but not limited to deviations and market action timely with timely implementation of CAPA requirements and its effectiveness.
Support non-GxP functions to develop and maintain proper documentation system and ensure document lifecycle management in place including standards/Procedure creation and retirements in addition to training requirements.
Lead regulatory inspections at the LOC for GMP/GDP/Product quality related activities and ensure that regulatory commitments are duly completed on time.
GxP (GMP/GDP/GCP/GVP) Supplier/Vendor Management System
Ensure risk based-qualified qualified GxP suppliers/Vendors are in place.
Monitor its ongoing quality performance including but not limited to deviations, product recalls, remedy plans,
Coordinate product/batch release between distributors and designated trading entities.
Manage product transportation Quality events which includes but not limited to temperature excursions, missed packs…etc.
Supports in GxP supplier/vendors qualification and monitoring programs; external quality audit plans, executions and establishment of GxP supplier quality agreements,
Perform customer bona fide checks, to ensure the appropriate & valid authorizations and licenses are in-place.
Quality Learning and Mindset Development
Manage and follow up on training and learning programs and its records for GxP functions,
Manage quality culture launches,
Plan and implement quality standards awareness and people capabilities developments