Quality Assurance Manager

About the role

Arcera, a global life‑sciences company, is seeking a Quality Assurance Manager for its Cairo site in al Obour City. Reporting to the Quality Site Head, you will lead the site Quality Management System and ensure compliance with GMP, EDA regulations and internal standards.

Key responsibilities

• Govern the Quality Management System: approve the Site Master File, SOPs, Validation Master Plan, audit reports and training plans.
• Oversee batch release, documentation control and final disposition of manufacturing and packaging records.
• Supervise equipment, facilities and utilities compliance, including preventive maintenance and calibration programmes.
• Manage quality risk and compliance: review deviations, change controls, complaints, recalls and CAPA effectiveness.
• Lead shop‑floor quality oversight, internal/external audits and regulatory inspections.
• Drive validation activities, annual product quality reviews and continuous‑improvement projects.
• Support people development, training and knowledge management within the QA team.

Required profile

• Bachelor’s degree in Pharmacy, Science or a related discipline.
• Minimum 10 years of Quality Assurance experience in pharmaceutical manufacturing.
• Proven leadership of quality teams and strong problem‑solving, documentation and audit capabilities.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• Experience with EDA regulations.
• Validation and qualification expertise.
• CAPA management.
• Audit and risk‑assessment skills.
• Preventive maintenance and calibration oversight.