Gestion de Deviations Pharmaceuticals [F/M/X]

Job description

Deviation Management Specialist

Key Responsibilities

• Lead the end-to-end management of deviations, including investigation, root cause analysis (RCA), impact assessment, and corrective and preventive actions (CAPA).

• Ensure all deviations are documented, tracked, and resolved in compliance with GMP (Good Manufacturing Practice), ISO 13485, and EU Directive 2001/83/EC.

• Collaborate with cross-functional teams (Production, R&D, QA, Supply Chain, Regulatory Affairs) to conduct timely and thorough investigations.

• Prepare and review deviation reports, investigation summaries, and management review documentation.

• Support audits (internal, external, regulatory) by providing evidence of deviation management processes.

• Identify trends and contribute to proactive risk mitigation strategies.

• Maintain and improve deviation management systems and workflows using digital tools (e.g., SAP QM, TrackWise, MasterControl).

• Mentor junior QA staff and ensure knowledge transfer.

Requirements

Education & Experience

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Biotechnology, or related scientific field.

• Minimum 5 years of experience in pharmaceutical quality assurance, with 3+ years focused on deviation management.

• Proven experience in GMP-regulated environments (manufacturing, packaging, testing, or clinical supply).

• Experience with CAPA systems, risk assessment tools (FMEA, HAZOP), and change control processes.

• Familiarity with EU GMP Annex 1, ICH Q7, FDA 21 CFR Part 211, and other relevant regulations.

Skills & Competencies

• Strong analytical and problem-solving skills.

• Excellent written and verbal communication skills (Spanish and English required; additional languages are a plus).

• Proficient in MS Office (especially Excel for data analysis).

• Experience with quality management systems (QMS) and digital platforms (e.g., TrackWise, SAP QM).

• Ability to work independently and manage multiple priorities under tight deadlines.

Preferred Qualifications

• Certification in Six Sigma, Lean, or Quality Management (e.g., ISO 9001 Lead Auditor).

• Experience in medical devices or biologics is advantageous.

• Knowledge of electronic batch records (EBR) and digital quality systems.

Why joining us?

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.