Senior Quality Assurance Specialist, Emerging Africa (Egypt)

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Summary

The Senior QA Specialist is responsible for implementing and maintaining Baxter's Quality Management System (QMS) and regulatory compliance activities in Egypt. The role ensures compliance with local regulations, Baxter Quality Standards, ISO 9001 and ISO 13485 requirements, while supporting product quality, patient safety, distributor and supplier oversight, regulatory activities, and business continuity through effective backup planning and training across English and French speaking Africa - Emerging Africa.

Key Responsibilities

Quality Assurance & Compliance

• Implement and maintain Baxter's QMS, policies, SOPs, and quality processes.
• Ensure compliance with local regulations, Baxter Quality Standards, ISO 9001, ISO 13485, GMP, and GDP requirements.
• Support internal and external audits, regulatory inspections, and corrective action implementation.
• Manage documentation, SOP lifecycle, training records, and quality system compliance.

Complaint Handling & Product Surveillance

• Act as Local Complaint Coordinator, ensuring effective complaint logging, investigation, reporting, closure, and authority notifications where required.
• Train customer-facing employees on complaint handling processes.
• Manage Medical Device Product Surveillance activities, including collection, reporting, and follow-up of adverse events and incidents.
• Maintain compliant surveillance systems and coordinate with relevant internal functions.

Field Actions & Product Safety

• Serve as Local Field Action Coordinator, ensuring timely execution, communication, reconciliation, and closure of field corrective actions.
• Coordinate communications with regulatory authorities and customers.
• Maintain trained backup coordinators for critical safety processes.

Distributor, Supplier & Third-Party Quality Management

• Manage distributor and third-party qualification, assessment, audit, and corrective action programs.
• Conduct GDP audits and ensure compliance with Baxter quality requirements.
• Establish and maintain QA Agreements with distributors, suppliers, and relevant partners.
• Maintain approved supplier lists and oversee supplier quality activities.

Quality Systems & Continuous Improvement

• Manage Non-Conformance Reports (NCRs), CAPAs, and Change Control processes.
• Investigate quality issues and drive timely implementation of corrective and preventive actions.
• Support continuous quality improvement initiatives across the region.

Product Release & Distribution Quality

• Ensure product release activities comply with local regulatory requirements.
• Ensure products are distributed only to authorized entities.
• Implement and maintain Good Distribution Practices throughout the supply chain.
• Manage temperature-controlled shipment quality requirements and oversee third-party warehouse quality standards.

Business Support

• Ensure appropriate procedures, training, and business continuity plans are in place for critical systems and processes.
• Maintain cross-functional collaboration with Supply Chain, Pharmacovigilance, Technical Services, Warehousing & Distribution, and Commercial teams.

Qualifications

• Strong knowledge of GMP, GDP, ISO 9001, and ISO 13485.
• Ability to collaborate effectively with internal and external stakeholders, including Regulatory Authorities, Pharmacovigilance, Supply Chain, Compliance, Technical Services, and third-party partners.
• Excellent communication, organizational, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Self-motivated, proactive, resilient, and able to work independently or within a team.
• Fluent in English.
• Preferred candidate location: Cairo, Egypt.

Education & Experience

• Pharmacy Degree required.
• Minimum 3 years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• Experience working within regulated healthcare environments and quality management systems.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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