CSV-Validation/(Good Clinical Practice)

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Anveta Inc, is seeking the following. Apply via Dice today!

This position involves validation strategy and planning, executing, and qualification of computer systems and/or infrastructure components in accordance with applicable policies, procedures, and regulatory requirements.

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 stakeholders, 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

Requirements:

Qualifications

Bachelor or Master''''''''s degree in Life Sciences or Computer Sciences
7-10 years'''''''' experience with Computer Systems Validation is required for this role
Strong knowledge of GxP Requirements, Google Cloud Platform 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 a must
Show more Show less