CQA Senior Specialist Emerging Africa at Baxter International

Cairo, Cairo Governorate, Egypt

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Minimum 5 years of experience in Quality Assurance or Regulatory Affairs in the pharmaceutical or medical devices sector
Fluency in English (French is a strong advantage)
Proven experience with auditing (internal/external)
Strong background in NCRs, Deviations, CAPA, Change Control, and QMS
Experience with Distributor and Supplier Management
Knowledge of product vigilance and field safety actions
Excellent communication, organizational, and multitasking skills
Ability to work independently with high initiative and accountability
No specific university degree required, but a degree in Pharmacy or Life Sciences is an advantage
Strong understanding of GMP, GDP, ISO 9001, ISO 13485, and regional regulatory frameworks
Excellent communication and leadership skills

Responsibilities

Act as Local Complaint Coordinator – ensure logging, investigation, and closure of product complaints
Oversee Product Surveillance for medical products and devices, including vigilance, field safety notifications, and reporting
Manage and execute Field Corrective Actions (FCA) and CAPA processes
Lead Distributor and Supplier Quality Management, including audits and performance monitoring
Manage Change Control, NCRs, and Deviations in compliance with corporate and local requirements
Ensure proper Product Release and selling authorization according to regulatory standards
Conduct and support Internal and External Quality Audits (GDP, GMP)
Oversee QMS & Documentation, including creation and implementation of SOPs
Provide training and guidance to internal teams and partners on quality systems and compliance
Collaborate with regulatory authorities and internal stakeholders (RA, PV, TS, W&D, Supply Chain)
Ensure compliance with local and corporate quality systems
Manage product vigilance and field safety activities
Support distributors and suppliers across the region

Skills

GMP

GDP

ISO 9001

ISO 13485

CAPA

NCR

Deviations

Change Control

Product Vigilance

Field Safety Notifications

Audits

Product Release

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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