Quality Specialist Operations

Il y a 4 semaines

PuursSintAmands Flemish Region, VLG, Belgique Pauwels Consulting Temps plein
Our client, a prominent pharmaceutical organization, is seeking a Quality Specialist Operations to focus on quality oversight and project support. The role involves managing operational quality tasks and ensuring compliance within a strictly regulated production environment. Responsibilities
- Investigate and document quality assurance deviations and escalate issues to management in a timely manner.
- Coordinate cross-functional investigations for complex root causes involving manufacturing, packaging, and laboratory operations.
- Perform root cause analyses and evaluate CAPA plans to verify effectiveness and prevent recurrence.
- Report significant quality issues to regulatory agencies in accordance with applicable legislation and standards.
- Participate in daily operations review meetings and multi-disciplinary process teams to ensure quality objectives.
- Conduct trending analyses and define necessary actions based on reports to optimize performance.
- Support continuous improvement initiatives to enhance departmental processes and key performance indicators. Requirements
- You bring 3+ years of experience in QA within a GMP environment.
- You have expertise in deviation management, root cause analysis, and CAPA.
- You possess experience providing quality oversight for manufacturing, packaging, or laboratory operations.
- You are proactive and solution-oriented. Nice to Haves
- Experience with regulatory reporting for international markets.
- Knowledge of continuous improvement methodologies.