QA Operations Specialist

Specific Skills Required :

• Knowledge of GMP (Good Manufacturing Practice)

• o Rigorous application of GMP requirements in production, quality control and documentation processes**.**

• Expertise in batch record review.

• o Ability to carry out detailed analysis of manufacturing records, identify discrepancies and ensure conformity of product release.

• Proven experience in the management of deviations and CAPAs

• o Ability to conduct complex investigations, identify root causes and implement corrective and preventive actions.

• Strong knowledge of change control systems

• o Impact analysis, cross-functional coordination and monitoring of implementation.

• Active participation in regulatory inspections and internal/external audits

• Strict compliance with Good Documentation Practices (GDP)

• o Accurate and compliant drafting and review of quality-related documents**.**

• Risk analysis and spirit of continuous improvement

• o Ability to carry out risk assessments (e.g. FMEA), suggest improvements and monitor key quality indicators.

• Solid understanding of pharmaceutical manufacturing processes

• Cross-functional leadership and strong teamwork skills

• o Close collaboration with production, quality control, engineering and regulatory affairs to ensure product quality and compliance**.**