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.