CSV Lead
CSV Lead
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1 Vacancy
Job Description
Job Title/Role: CSV Lead
Client: HCL
Exp: 12
Job Location/Client Location (with City & State): King of Prussia PA
Mandatory Skills Computer System Validation Computed system assurance GAMPGxP risk assessmentsChange Management
JD
12 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 CSL roles such as CSA Validation SME and Test Manager as required by CSL 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
Thank You.
Employment Type
Full-time
