Quality Operation Specialist

About the role

Thermo Fisher Scientific is seeking a Quality Operation Specialist to join its Quality Assurance team. The role ensures compliance with GMP and cGMP standards across manufacturing operations and supports continuous improvement of product quality.

Key responsibilities

• Follow site safety requirements and maintain a safe working environment.
• Provide shop‑floor QA oversight and problem‑solving support to manufacturing operations.
• Perform quality monitoring for aseptic manufacturing processes and conduct acceptable quality checks for sterile products.
• Review QC documents, support operational readiness programs, and assist the QA manager with batch disposition and validation documentation.
• Assess incoming materials for new product introductions, write operational procedures, and review SOPs.
• Collect and analyse shop‑floor information, resolve issues, and act as QA representative.
• Review and approve Master Batch Records and Master Formulation Records ensuring compliance with TFS standards and cGMP.
• Prepare for GMP and client audits, participate in deviation and OOS investigations, and lead root‑cause analysis with CAPA implementation.
• Support process validation, clean validation review, and continuous improvement of QA operations procedures.

Required profile

• Experience in quality assurance within a regulated manufacturing environment.
• Strong knowledge of Good Manufacturing Practices (GMP) and current GMP (cGMP) requirements.
• Ability to lead investigations, perform root‑cause analysis and implement corrective and preventive actions (CAPA).
• Familiarity with batch disposition, master records review, and regulatory audit readiness.

Required skills

• GMP / cGMP compliance
• Aseptic manufacturing processes
• Computer system validation
• Root cause analysis
• CAPA management
• Batch disposition
• Master Batch Record review
• Quality monitoring and acceptable quality checks