QC Incoming Materials Sampling Senior Specialist

About the role

Arcera, a global life sciences company developing, manufacturing and commercializing medicines, is hiring a QC Incoming Materials Sampling Senior Specialist. The role inspects, samples and identifies incoming raw and packaging materials against approved specifications, cGMP requirements, company procedures and regulatory standards, and supports quality, compliance and continuous improvement. It reports to the Quality Control Section Head and is based at the manufacturing site in Al Obour City, Cairo.

Key responsibilities

• Perform and review inspection, sampling and identification of incoming materials according to the required specification, and prepare and review the sampling documents.
• Carry out daily calibration checks of sampling equipment and verify that the sampling room complies with cGMP.
• Record inspection results on the SAP system and share in preparing the annual purchasing plan for sampling reagents and tools.
• Take part in investigations of out-of-specification results, deviations and unidentified raw materials, conduct root cause analysis and support CAPA implementation.
• Support regulatory inspections, customer audits and internal audits, and ensure compliance with cGMP and data integrity requirements.
• Help prepare and revise SOPs, specifications and risk assessments.
• Train and mentor incoming materials sampling specialists and junior specialists, and support competency assessments.

Required profile

• Bachelor's degree in pharmacy, science or a related field.
• Minimum 4 to 6 years of experience as a QC incoming materials sampling senior specialist in a pharmaceutical company.
• Good command of English.

Required skills

• Strong knowledge of GMP and sampling requirements.
• Advanced troubleshooting and investigation skills, with root cause analysis and risk assessment capability.
• Excellent technical writing and documentation review skills.
• Strong communication and collaboration abilities.