​​Mantell Associates is partnered with a growing organisation who are searching for a Senior CSV Officer.

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Senior CSV Officer Responsibilities:

• Create key CSV deliverables and/or assist business units in writing CSV documentation (e.g., Validation Plan, Functional Requirements Specification, Test Scripts, Validation Report), based upon approved templates / processes and ensures proper filing in respective document management system

• Review vendor validation documentation and provide documented feedback and guidance

• Execute Impact / Risk Analysis and document respective outcome

• Support the analysis and monitoring of security processes and incidents

• Support maintenance of e.g., system inventories, changes, incidents, etc, ensuring accuracy and completeness at all times

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Senior CSV Officer Requirements:

• At least a Bachelor in Sciences or in IT with 5-6 years working experience as CSV in the pharmaceutical industry

• CSV Experience in a GCP environment

• Auditing experience in the pharmaceutical industry is a plus

• Data Integrity experience project is a plus

• Excellent writing skills for scientifically sound technical documents, instructions, validation protocols and reports in English, French is an asset

• Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.