IT QA Lead

About the Company

United Consulting Hub delivers specialized

validation and quality solutions across the life sciences industry, supporting clients with Computer Systems Validation, Equipment & Process Validation, QA, QC, Microbiology, and Regulatory Affairs.

We are seeking an experienced

IT Quality Assurance Specialist / Lead

to support GxP computerized systems and IT compliance within a pharmaceutical manufacturing environment. The role will provide quality oversight across validation, data integrity, change control, deviations, CAPA, audits, and system lifecycle activities.

Position: IT Quality Assurance Specialist / Lead

Industry: Pharmaceutical Manufacturing

Location: NJ

Key Experience

• 5–10 years of experience in

IT QA, CSV, CSA, or GxP IT Compliance

• Pharmaceutical, biotech, medical device, or regulated life-sciences experience
• Strong experience with

Computerized System Validation (CSV)

and

Computer Software Assurance (CSA)

• Knowledge of

GAMP 5, FDA 21 CFR Part 11, 210/211, EU GMP Annex 11, ICH Q9/Q10, and ALCOA+

• Experience reviewing

URS, validation plans, risk assessments, FS/DS, IQ/OQ/PQ, RTM, and validation reports

• Experience with GxP systems such as

SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS, EMS, and data historians

• Strong understanding of

data integrity, audit trails, access controls, backup/recovery, electronic records, and system security

• Experience with

change control, deviations, CAPA, periodic reviews, incident management, and system decommissioning

• Audit and regulatory inspection support experience
• Experience with

supplier/vendor qualification and cloud technology compliance

• Strong documentation, communication, risk assessment, and stakeholder-management skills

Preferred Certifications

• GAMP 5 / CSV certification
• ASQ Certified Quality Auditor
• ITIL Foundation
• ISO 27001 / CISA / CISSP
• Project Management or Agile certification

Interested?

Send your updated resume to navya@unitedconsultinghub.com