Documentation Officer – Planning & Support Office

About the role

The Documentation Officer will support the Planning & Support Office by ensuring all manufacturing documentation complies with internal quality standards and GMP requirements. You will work on master batch records, bills of materials, procedures, and investigation reports for commercial products and new launches.

Key responsibilities

• Generate and revise master batch records and bills of materials for inspection, labeling, and packaging activities.
• Create and update procedures (APAIs, VPAIs, Wis) in line with change controls and risk assessments.
• Perform root‑cause investigations, impact analyses, and write investigation reports for manufacturing operations.
• Collaborate with Operations Supervisors/Managers to propose and define CAPAs based on trending investigations.
• Issue memos for manufacturing activities and produce monthly KPI and investigation reports.

Required profile

• Bachelor’s degree in a technical, scientific, engineering or medical field.
• 3‑5 years of experience in pharmaceutical operations or quality departments.
• Proactive, organized, and able to work independently or within a team.
• Fluent in written and spoken English.

Required skills

• Microsoft Word, Excel, PowerPoint.
• Root‑cause analysis techniques (e.g., FMEA).
• Good Manufacturing Practices (GMP) compliance.
• GXP Quality Assurance knowledge.
• Understanding of pharmaceutical manufacturing processes.

What we offer

• Direct contract with Hikma.
• Competitive salary.
• Life and health insurance.
• Annual performance bonus.
• High career prospects.