Sr. Clinical/ CSV Validation Consultant

Zifo • Warren Township, NJ

1d

About The Position

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. 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.

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

• 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
• 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

Benefits

• accrued vacation
• medical
• dental
• vision
• 401k with company matching
• life insurance
• flexible spending accounts

What This Job Offers

• Job Type: Full-time
• Career Level: Senior