Batch Record Review And Investigation Specialist

We are currently looking for a Batch Record Review and Investigation Specialist to join our client, a leading pharmaceutical company located in Frosinone, Italy. This is a temporary position with a contract duration of 6 months, with the possibility of extension.

Responsibilities:
- 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
- Proficient in Italian. 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


Lingue conosciute:
Inglese: Comprensione Buono

Disponibilità oraria: Full Time, Disp. Turni con notte

Patente: B

Mezzo di trasporto: Auto,
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