Cleaning Validation Expert

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

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