QA Lead-Computer System Validation

Company: Central Business Solutions
Location: Santa Monica
Posted on: March 17, 2023

Job Description:

Position Role/Tile: -QA Lead-Computer System Validation

Location: -Santa Monica, CA .

Job Responsibilities:

Participate in meetings (status updates, aligning with stakeholders, resolving questions from cross functional teams)

Change control CSV impact assessments (meeting with stakeholders for COI/COC systems)

Review change control records

o EBS change control records

o Kite change control records (pre-approval and action items, completed action items, CC closure)

Draft plans (Val plan or Computer System Change Assessment) and draft VSR

Reviews (SDLC documents, post-executions, EC's)

UAT sit-in sessions to ensure requirements are being followed if UAT is being leveraged for PQ, defect reviews/approvals

Kite Konnect hotfixes/emergency fixes (review TIA, review evidence)



Qualifications:

Experience in startup or fast paced company, nice to have experience in cell therapy company

Extremely detail-oriented

Good in taking direction

Effective communicator

Good education

Easy to work with personality

Have at least 5+ years experience leading CSV projects from beginning to end, creating all SDLC documents, data migrations, system decommissioning

Familiar with regulations 21 CFR Part 11, EU Annex 11, data integrity principles, GDP

Central Business Solutions, Inc,

37600 Central Ct.

Suite #214

Newark, CA 94560.

Keywords: Central Business Solutions, Santa Monica , QA Lead-Computer System Validation, IT / Software / Systems , Santa Monica, California