Documentation Officer – Production

About the role

The Documentation Officer will support the Production department at Hikma's Portugal site, ensuring all documentation complies with internal quality standards and GxP/GMP regulations. You will act as a subject‑matter expert for production investigations and provide training to staff.

Key responsibilities

• Stay updated on internal quality standards, GxP/GMP compliance and best practices.
• Perform, evaluate and write root‑cause investigations and impact analyses for production deviations.
• Collaborate with operators, supervisors and managers to define CAPAs based on root‑cause analysis and trend data.
• Draft production reports (investigations, memos, protocol reports) and standard operating procedures.
• Serve as SME for production investigation reports and deliver training sessions, including annual cGMP training.

Required profile

• Degree in a technical, engineering, scientific or medical field.
• 3–5 years of experience in pharmaceutical operations or quality departments (preferred).
• Proactive, organized and familiar with GMP, pharma quality standards and GxP quality assurance.
• Knowledge of root‑cause analysis techniques and product impact tools such as FMEA.
• Strong computer skills (Word, Excel, PowerPoint) and fluency in written and spoken English.

Required skills

• Word
• Excel
• PowerPoint
• FMEA
• Root cause analysis
• GMP
• GxP
• CAPA development
• SOP writing
• English (written & spoken)

What we offer

• Direct contract with Hikma
• Salary commensurate with the role
• Life and health insurance
• Annual performance bonus
• High career prospects