GxP Validation & Test Lead – QA & Delivery

First Soft Solutions; Rockville (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

First Soft Solutions in Princeton, NJ is seeking a Validation Analyst/Lead with hands-on Computer System Validation experience in GxP systems and medical device software. A minimum of 8 years in the field is required.

You will work with Argus, Documentum, TrackWise and HP ALM, performing IQ/OQ/PQ and applying GAMP5 risk-based testing. Strong client-facing and independent-work abilities are valued.

Qualifications

• Minimum 8 years of CS Validation experience.
• Hands-on end-to-end validation for GxP systems.
• Experience with medical device software.
• Familiarity with IQ/OQ/PQ and GAMP5.
• Client-facing and collaboration with teams.

Responsibilities

• Lead validation projects for GxP systems.
• Perform IQ/OQ/PQ for validated applications.
• Maintain hands-on experience with Argus, TrackWise, Documentum.
• Collaborate with clients and internal teams.
• Adhere to GxP and quality standards.

Skills

Computer System Validation

GxP systems

Argus

Documentum

TrackWise

HP ALM

Tools

HP ALM

Argus

Documentum

TrackWise

Job description

First Soft Solutions in Princeton, NJ is seeking a Validation Analyst/Lead with hands-on Computer System Validation experience in GxP systems and medical device software. A minimum of 8 years in the field is required.

You will work with Argus, Documentum, TrackWise and HP ALM, performing IQ/OQ/PQ and applying GAMP5 risk-based testing. Strong client-facing and independent-work abilities are valued.