Batch Record Review and Investigation Specialist

Settore: / Farmaceutico /
Azienda: Adecco Italia Spa
Data annuncio: 21/05/2024
Sede di lavoro: Frosinone

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.

- 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

Categoria Professionale: Assistenziale / Paramedico / Tecnico

Città: Frosinone (Frosinone)

Conoscenze linguistiche:

  • Inglese - Livello Buono


  • B

Mezzi di trasporto:

  • Auto

Disponibilità oraria:

  • Full Time
  • Disp. Turni con notte

I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy consultabile sotto il form di richiesta dati della pagina di candidatura (Regolamento UE n. 2016/679).

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