Senior CSV Officer - Small Molecule

Posted 18 April 2023
Salary Competitive
Job type Full Time
Discipline Small Molecule
Contact NameThomas White

Job description

​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.