Information Technology Quality Assurance

Role:

-IT Quality Assurance Specialist / Lead

Industry: Pharmaceutical Manufacturing (MUST)

Location:
New Jersey,USA

Employment Type: 12+ Months W2 Contract

Experience: 5–10 Years

Job Summary :

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We are seeking an experienced IT Quality Assurance (ITQA) Specialist/Lead to support GxP computerized systems and IT compliance within a pharmaceutical manufacturing environment. The role will provide quality oversight for CSV/CSA, data integrity, change control, deviations, CAPA, audits, and system lifecycle management
.

Key Responsibilities :

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• Provide ITQA oversight for GxP computerized systems
  , including SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS, EMS, historians, and laboratory systems
  .
• Review and approve URS, risk assessments, validation plans, FS/DS, IQ/OQ/PQ, RTM, validation reports, and system release/retirement documents
  .
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, ICH Q9/Q10 and applicable GxP requirements.
• Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities.
• Manage quality oversight for change controls, deviations, CAPA, incidents, periodic reviews, and system lifecycle activities
  .
• Evaluate data integrity, audit trails, user access, electronic signatures, backup/recovery, data migration, and disaster recovery controls
  .
• Support internal audits, supplier audits, FDA/regulatory inspections, and inspection readiness
  .
• Participate in vendor/cloud qualification and supplier compliance assessments
  .
• Collaborate with QA, IT, Manufacturing, Engineering, QC, Automation, Warehouse, and system owners
  .

Required Qualifications :

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• Bachelor’s/Master’s degree in Computer Science, IT, Engineering, Pharmacy, Life Sciences, or related field
  .
• 5–10 years of ITQA, CSV, CSA, or GxP IT Compliance experience.
• Pharmaceutical, biotech, medical device, or other regulated life-sciences manufacturing experience.
• Strong knowledge of GxP regulations, data integrity, validation lifecycle, change control, deviations, and CAPA
  .
• Experience with SAP, MES, LIMS, QMS, SCADA, PLC, BMS/EMS, or data historians is preferred.
• Strong documentation, analytical, communication, and stakeholder-management skills
  .

Preferred

Certifications:

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GAMP 5/CSV, ASQ CQA, ITIL, ISO 27001, CISA, CISSP, or Project Management/Agile.