Validation Assistant - Noventa Padovana, Italia - BI AH IT

BI AH IT

Azienda verificata

Noventa Padovana, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

The Position:

In this position you will join the Validation team in the Boehringer Ingelheim production site in Noventa Padovana (PD), where veterinary vaccines are manufactured.

You will support the team in ensuring that processes and the qualification of equipment are in validated status according to GMPs and BIAH guidelines.

**For this role we offer a two year fixed term contract.

Tasks & Responsibilities:

Writing, verification and execution/supervision of validation protocols
Drafting of validation reports and any Risk Assessment
Issuance and review of validation documentation and related SOPs, ensuring GMP documentation in line with ALCOA principles.
Collaboration with the production department for writing procedures and/or batch records and organizing/planning validation activities.
Collaboration with QC for test planning and receipt of samples during planned validations
Participation in internal and authority audits, to ensure compliance with national and international regulations, quality requirements and guidance documents.
Ability to analyze validation and manufacturing data to evaluate compliance with GMP requirements and/or resolve compliance issues.
Conducting training to staff and other departments on quality and validation principles

Requirements:

Minimum 2 years of experience in a similar role in chemical/pharmaceutical area (experience in the biological sector would be a plus)
Degree in scientific disciplines (CTF, pharmacy, chemical engineering or biology)
Excellent knowledge of GMP and the quality system
Experience in the CSV/Data Integrity completes the profile (Annex 11 ed. curr.)
Good Knowledge of English (level B2/C1) and Excellent Italian Language
Excellent knowledge of Microsoft Office (Word, Excel, Outlook, PowerPoint).
Good organizational skills, ability to work in team/individually also within critical or complex situation Proactive with good influencing skills