Validation Lead - CSV

TechDigital Group; King of Prussia (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

TechDigital Group is seeking an experienced CSV and QA professional in the United States (King of Prussia area) to lead validation activities for GxP systems. You will perform end-to-end system validation, risk assessments, and change management within FDA GxP contexts and regulatory standards.

The role requires expertise with ALM/DMS/JIRA tools, familiarity with SAP, serialization, and MES environments, and the ability to work in Agile and Waterfall projects.

Qualifications

• 10+ years of experience validating systems in GxP environments.
• Experience in CSV activities for SAP, Product Serialization and MES systems.
• End-to-end validation knowledge and ability to assess regulatory compliance.

Responsibilities

• Review system assurance deliverables to ensure regulatory compliance.
• Perform validation activities using Agile and Waterfall methodologies.
• Develop and maintain Validation Plans and Validation Summary Reports with traceability matrices.
• Lead change control, risk assessments and RTM updates for GxP systems.
• Coordinate QA activities and collaborate with regional stakeholders.

Skills

Computer System Validation

GAMP

GxP risk assessments

Change Management

JIRA

Veeva / Argus

Tools

ALM

DMS

JIRA

Job description

Mandatory Skills

CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools JIRA

JD:

Primary Skill - Computer System Validation, computed system assurance, GAMP, GxP risk assessments, Change Management
Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology
10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology
Activities Requirement Specifications, Functional Specifications User Stories / Acceptance Criteria and ensures completeness of test script with traceability Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement Ensures pre-executed test protocol has the necessary test data requirements to run the tests Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process Able to author Validation Plan and compile Validation Summary Report and generates RTM Reviews and ensures that the Operational Procedure for the application is ready Is able to handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM Prior experience in using tools like ALM, DMS and JIRA Good to have experience in implementing US-DSCSA
- Single point of contact for Geo and functional specific scope of services related to system assurance and compliance role including CSA, Val SME and test management.
- Responsible for Geo and functional specific service quality, performance and customer satisfaction, demand management
- Perform roles such as CSA, Validation SME, and Test Manager as required by client's QMS.
- Build and manage relationship with regional stakeholders including gathering and resolving feedback
- Review system assurance and compliance deliverables and guide team on daily basis