CSV Engineer

Quanta part of QCS Staffing; France; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading global biopharmaceutical organization seeks a CSV Engineer / Lead for a 12-month contract in a charming French location. The role focuses on Computerised Systems Validation, ensuring compliance and quality during the expansion project while managing risks to product quality and patient safety.

Qualifications

• Site Subject Matter Expert for Computerised Systems Validation.
• Experience with GAMP compliance.
• Ability to manage validation resources.

Responsabilités

• Develop and manage the site strategy towards CSV.
• Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
• Support development of CSV competencies within the business.

Connaissances

Risk Management

Computerised Systems Validation

Cross-Functional Collaboration

Regulatory Compliance

Description du poste

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CSVEngineer / Lead -Hauts-de-France- 12-Month Contract

Our client, aglobal (bio)pharmaceutical manufacturing organisation, is recruiting for aCSVEngineerto 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 and Requirements:

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.

Support vendors to ensure adherence to, and application of GAMP

Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.

Work cross-functionally to ensure site alignment with lifecycle requirements.

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.

Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment always meets regulatory requirements with a target of zero impact to routine operations.

Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.

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.

Application of risk and science-based tools to drive execution strategies and support issue resolution.

If this role is of interest to you, please apply now!

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