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.