Senior Quality Control Specialist (IRM / IPM)

About the role

Arcera, a global life sciences company developing, manufacturing and commercializing medicines, is hiring a Senior Quality Control Specialist (IRM / IPM) for its manufacturing site in Al Obour City, Cairo. The role covers the timely and compliant physical and chemical testing of incoming raw materials (APIs and excipients), packaging materials and purified water to support production plan completion. It also involves leading or supporting investigations, method transfer or validation, and helping to train junior analysts. The position is full-time and on-site, reporting to the QC Section Head.

Key responsibilities

• Perform compendial and in-house testing using classical chemistry and instrumental analysis methods.
• Review manufacturers' certificates of analysis and specifications of incoming raw material lots against current pharmacopeial monographs before analysis.
• Document analytical steps, raw data and calculations contemporaneously in worksheets, logbooks, LIMS or SAP according to ALCOA+ principles.
• Verify instruments and glassware internally and follow calibration schedules; monitor lab and sample room environmental conditions via data loggers.
• Adhere strictly to cGMP, internal SOPs and pharmacopeial monographs (USP, EP, BP).
• Lead or support OOS investigations, root cause analysis, CAPA actions and risk assessments.
• Train and onboard junior specialists and trainees, and support audits and inspections.
• Draft protocols and execution plans for analytical method verification and compendial method transfer, and create and update SOPs and work instructions.
• Promote laboratory safety and EHS compliance, prepare and standardize reagents and volumetric solutions, and share in preparing the annual reagent purchasing plan.
• Support other QC departments, including finished product release and stability backlog.

Required profile

• Bachelor's degree in Pharmacy or Science (Chemistry).
• 5 to 8 years of experience.

Required skills

• Analytical chemistry and instrumental analysis
• GMP and regulatory compliance
• Data integrity (ALCOA+)
• Investigation and root cause analysis
• Attention to detail