Cleaning Validation Expert - Siena, Italia - Adecco Italia

Adecco Italia

Azienda verificata

Siena, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

For a pharmaceutical company, we are looking for a:

CLEANING VALIDATION EXPERT

Purpose of the role:
Support cleaning validation strategies and activities related to drug substance/drug product manufacturing (Primary and Secondary operations). The position executes assigned activities related to the three steps of the Cleaning Validation lifecycle

Main activities:

Responsible for the writing, review and approval of validation documents (Protocol, Report, Cleaning Risk Assessment, Cleaning monitoring, Cleaning Verification)
Ensure alignment of Validation dept across stakeholders, i.e. Production, QA, QC, Supply and every other function involved in the validation activities
Guarantee the proper training of the production personnel to the cleaning validation samplings
Actively contributes to change control management, investigations and CAPA implementation;
Supports his/her manager to department KPIs definition/monitoring and improvement;
Supports her/his manager in coordinating the daily activities prioritization
Is able to evaluate and assess current practices versus regulatory requirements and current industry best practices, identifying possible gaps, set up and execution of remediation plans, including resources needs;
Maintain updated his/her training status and support the training of new personnel;
Support actively Regulatory Authorities inspections, divisional audits and internal audit in back office/preparation of the validation points;

Minimum requirements:

University Degree in scientific field (i.e. Engineering, Biology, Chemical, Pharmacy)
Strong technical skills, including manufacturing systems and control, quality systems, MS
Office Applications.
Knowledge of guidelines and pharma rules (GxP, ISO, ICH, etc.) requested by the main Regulatory Authorities (FDA, AIFA, EMA, etc ).
Risk Management, Problem Solving skills.
Good knowledge of spoken and written English

Data inizio prevista: 03/07/2023

Categoria Professionale:
Scientifico / Farmaceutico

Settore:
INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA

Città:
Siena (Siena)

Disponibilità oraria:

Full Time

ATTENZIONE:

Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa al seguente link.

Adecco Italia S.p.
A. (Aut. Min. Prot. N.1100-SG del