- Manage nonconformities and deviations raised from all departments of the site
- Manage OOS and OOT as per GMP guidelines
- Root Cause analysis and problem solving
- CAPA definition and follow up activities
- Cooperate with the other departments for the investigation of complaints received from the Customers.
- Organize tasks based on priorities, identify critical issues, and plan strategies to meet production-defined timelines and ensure on-time the release of batches required by Supply.
- Open Change Controls
- Take part during audit from Customers and Regulatory Authorities
- Responsible for the review and approval of cGMP documentation against Standard Operating Procedures in order to ensure compliance in Manufacturing processes.
- Review batch records. Cross-check against specifications for accuracy, completeness, and to identify any potential issues
Minimum skills required:
- Bachelor Degree, preferably Chemical or Pharmacy
- At least 2 years experience in a similar role
- Fluent knowledge of English (written and spoken).
- Good Communication skills.
- Able to work as part of team and adapt to changes in work duties
- Detail-oriented, thorough and methodical, and able to follow timeline
Categoria Professionale: Scientifico / Farmaceutico
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Frosinone (Frosinone)
- Quality Assurance Specialist - Settore industriale: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
- Inglese - Livello Buono
Mezzi di trasporto:
- Full Time