Validation Lead - CSV

Job Title

Computer System Validation Expert

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

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

Activities: Requirement Specifications, Functional Specifications, User Stories / Acceptance Criteria, 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