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Quality Lead

2 weeks ago

مصر, Egypt Takeda Pharmaceutical Full time

**OBJECTIVES**:
To deploy Takeda global quality management system within Takeda Egypt and Algeria, executing effective quality management system on local level to ensure compliance with applicable laws and regulations. Develop country quality plan and execution. Report on local QMS performance and plans for improvement.

**ACCOUNTABILITIES**:
Quality Management System
- Implement Takeda global quality management system across Takeda Egypt and Algeria GxP functions.
- 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 County Quality Plan for Egypt and Algeria. Follow up on quality requirements for new product launches and ensures risk mitigation plans are fulfilled as per Takeda global quality standards.
- Plan and execute local risk-based self-inspection as per related Takeda global QMS to evaluate compliance with product quality systems & processes in LOCs, 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 LOCs 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.
- Lead regulatory inspections at the LOC for GMP and GDP related activities and ensure that regulatory commitments are duly completed on time.
- Implement quality risk management to proactively assess, control, review and communicate potential risk

GxP 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.
- Perform 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 GxP training and learning programs and its records,
- Manage quality culture launches,
- Plan and implement quality standards awareness and people capabilities developments

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:
**Education**
- University degree in Pharmaceutical Science, Pharmaceutical Technology, Microbiology or Chemistry Science.
- Minimum of 7-10 years in a QA/QC position in pharmaceutical industry Possesses appropriate quality and technical experience.
- Experienced in quality management system implementation and GMP/GDP/GVP/GCP suppliers oversighting with strong cGMP knowledge.
- Holding TQM and/or Six Sigma certification is preferred.
- Familiarity with local and international GxP regulations.
- Critical Thinking skills.

**Business skills and knowledge**
- Ability to make sound and effective quality decisions,
- Able to work independently.
- High level of time management and use of planning tools.
- Fluent in written and spoken Arabic and English.
- French speaking and writing are preferred.
- Adept in leading investigation and problem-solving.
- Strong communication and stakeholder management skills.

**Locations**:
Egypt

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time