CSV Engineer

Quanta part of QCS Staffing; Toulouse; Sur place; EUR 45 000 - 60 000; Plein temps

Résumé du poste

A leading staffing agency is looking for a CSV Engineer for a contract role in Toulouse, France. The successful candidate will manage the computerised systems validation strategy and ensure compliance with quality standards. This position focuses on developing risk-based testing strategies to maintain product quality and involves team development and strategic oversight. Interested candidates are encouraged to apply immediately.

Qualifications

• Experience in Computerised Systems Validation within a pharmaceutical or biotechnology environment.
• Knowledge of regulatory compliance and validation standards.

Responsabilités

• Act as Site Subject Matter Expert for Computerised Systems Validation.
• Develop and manage the site strategy towards CSV.
• Manage risk-based testing strategies to ensure product quality.

Connaissances

Computerised Systems Validation

Risk Management

Quality Assurance

Team Development

Description du poste

Overview

CSV Engineer – Toulouse – Contract – Life Sciences

Our client, aglobal (bio)pharmaceutical manufacturing organisation, is recruiting for CSV Engineer to join them on their new expansion project. Based in a charming French location, this is on a contractual basis, and will involve significantly growing the sites capacity for the manufacture ofBiologics.

Responsibilities

• Site Subject Matter Expert for Computerised Systems Validation.
• Responsible for developing and managing the site strategy towards CSV.
• Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
• Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
• Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
• Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
• Support development of CSV competencies within both Validation and across the business.
• Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
• Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
• Highlight risks to product quality, patient safety and / or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
• Identify skills and competency development needs within the team.
• Support Validation Management in the identification, recruitment, and on-boarding of resource (staff and contract) into the organisation.
• Ensure that the performance of the personnel (internal and external) operating under your remit meets the standards (competence and behavioural).
• Ownership of commissioning, qualification, and validation implementation within your remit and, inconjunctionwith your peer group, across the validation team to ensure consistent service delivery and systemic application of process improvements.

If this role is of interest, please apply now.