Category QualityPublish Date Wednesday 13-08-2025Country EgyptGender anyYears Of Experience 6 - 9 YearsSalary NegotiableSenior Quality Assurance is required for a multinational Health Care company located in New Cairo.Senior Quality Assurance is required for a multinational Health Care company located in New Cairo.Responsibilities:
Providing QA support for assigned TPM’s and/or Suppliers to ensure that safe, efficacious, and quality product can be supplied to EMEA region to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
Managing TPM & Supplier activities while driving continuous improvement for TPMs and Suppliers.
Responsible for Monitoring quality performance for assigned TPMs / suppliers and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs and suppliers.
QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM and supplier sites.
QA lead for co-ordination with TPMs & Supplier and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
Act as QA Lead for below quality activities during Product Technology Transfer including Change Control, Stability and Change Impact Assessment, Test Method Transfer, Validation/Verification, Process Validation/Verification Program, First lot quality review.
Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards.
Requirements:
Bachelor’s degree in science, Pharmacy or equivalent level of education at a relevant scientific discipline.
Minimum 5 years of experience in the pharmaceutical manufacturing field (Quality, production, Validation, technical support, etc.).
Excellent communication and report writing skills in English and Arabic, with fluent spoken English.
Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
Knowledge of international and local quality system and compliance legislations and standards.
GMP/GLP/GCP background related to medicinal products, medical device, food supplement, Biotechnological, Biosimilars and Biologics.
