Responsibilities:

• Providing QA support for assigned TPMs to ensure that safe, efficacious, and quality product can be supplied 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.
• Responsible for Monitoring quality performance for assigned TPMs, and ensure requirements per Quality Technical Agreements are adhered and followed by assigned TPMs.
• QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM sites
• QA lead for co-ordination with TPMs and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
• Responsible for maintaining regional Approved TPM Listing.
• Responsible for communication with Global TPM QA regarding Global TPM Products that are supplied for Egypt, part of EMEA region.
• Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.
• Support new contract manufacturing site approvals within responsibility in Egypt.

Requirements:

• Bachelor’s degree in science, Pharmacy or equivalent level of education at a relevant scientific discipline.
• Minimum 10+ years of experience in the pharmaceutical manufacturing field (Quality, production, technical support,etc).
• 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.