Job description
Mantell Associates is representing one of the most exciting Biopharmaceutical organizations globally speaking who are looking for a Senior CSV Specialist to join their team.
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
Provide CSV training as appropriate for users of specific systems
Closely collaborate with the CSV Lead, Business Process Owner and System Owner and understand the synergy between business, Quality and IT
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
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Conor.osullivan@mantellassociates.com or 786-245-8592