QA Senior Specialist - Sterile Area

About the role

Arcera, a global life sciences company developing, manufacturing and commercializing medicines, is hiring a QA Senior Specialist for its sterile production area. You will monitor manufacturing and packaging processes to ensure they follow GMP procedures and report any violations. The position reports to the QA Senior Section Head of the sterile area and is based at the Cairo site in Al Obour City.

Key responsibilities

• Monitor production processes against batch records to ensure GMP compliance and prevent deviations.
• Enter manufacturing and expiry dates for the monthly ampoule plan in SAP.
• Review and approve monthly ampoule films for printing.
• Collect and review batch record documents for market release and record data in the annual product review template.
• Report violations to the compliance team, ensure root causes are identified and corrective actions implemented.
• Take part in annual quality self-inspection plans to detect and address deviations in manufacturing practices.

Required profile

• Bachelor's degree in pharmacy or science (Chemistry).
• 3-5 years of work experience.
• Excellent English proficiency and communication skills.
• Highly detail-oriented, with decision-making and problem-solving skills and the ability to handle stress effectively.