Senior Clinical- Computer Systems Validation Consultant

Zifo•Warren, NJ

21h•Onsite

About The Position

Zifo is hiring! We are looking for a Senior Clinical CSV Consultant to join our team in Warren, NJ. This person will be responsible for validation strategy and planning, executing and qualification of computer systems and/or infrastructure components in accordance with applicable policies procedures and regulatory requirements.

Requirements

Bachelor or Master’s degree in Lifesciences or Computer Sciences
7-10 years’ experience with Computer Systems Validation is required for this role
Strong knowledge of GxP Requirements, GCP regulations, 21 CFR part 11 requirements
Must have experience with validation of IT infrastructure systems including R, SAS etc.
Experience with GxP systems validation like ELN, LIMS, QMS etc.
Experience with Veeva Vault Systems
Clinical experience is must.

Responsibilities

Define validation Strategy for computerized systems and platforms utilized in GxP Space
Create Validation deliverables such as Validation Plan, Test Protocols, Traceability matrix and execution of protocols
Participate in user review meetings, discussions with Quality Assurance and Compliance groups
Participate/conduct Risk Assessments
Develop and maintain policies and procedures
Effectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within Zifo
Act as a liaison between Zifo remote teams and customers in US & Canada
Participate in internal initiatives around Computer Systems Validation