Documentation Specialist (Commissioning and Qualification)

Responsibilities

• Elaborate and review qualification protocols (DQ, IQ, OQ, PQ) to ensure alignment with regulatory standards
• Document and validate execution evidence during qualification phases
• Draft technical reports supporting validation test results
• Manage addendums to qualification protocols based on technical or regulatory changes
• Consolidate technical dossiers per project, ensuring integrity and completeness
• Coordinate documentation for FAT (Factory Acceptance Test) and SAT (Site Acceptance Test)
• Identify, register, and follow up on deviations to ensure timely closure
• Control and document changes in processes or equipment to maintain traceability
• Update traceability matrices to ensure correlation between requirements, tests, and results
• Organize and structure digital documentation in management platforms
• Collaborate on updating technical drawings derived from executed projects
• Participate in documentary audits, addressing observations and proposing corrective actions

Requirements

• Bachelor's degree in Engineering (Chemical, Industrial, Biomedical, Mechanical, or similar), Pharmaceutical Sciences, or related technical careers
• Minimum 3 years of experience in technical project document control and quality documentation management in regulated industries
• Valid DC3 certification (indispensable)
• Proficiency in document control systems such as SharePoint or EDMS
• Knowledge of DQ, IQ, OQ, PQ packages and technical closing dossiers
• Familiarity with GMP regulations and applicable standards
• Technical English (desirable)

Preferred Qualifications

• Certifications in GMP, ISO, or quality management standards

Benefits

• Base salary
• Major Medical Expense Insurance (includes dental and vision plan)
• 15 days bonus
• 25% vacation bonus
• 12 days of vacation (from the first year)
• Social Security
• PTU/Profit Sharing