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