CSV LEAD CONSULTANT
CSV LEAD CONSULTANT
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- 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 USDSCSA.
- 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.
Requirements:
- Computer System Validation Computed system assurance GAMP GxP risk assessments Change Management.
- 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 endtoend validation of GxP applications and is able to perform document process Compliance.
- Analysis Adept with Agile and Waterfall methodologybased 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 preexecuted test protocol which includes all the basic elements of a test script completeness and appropriateness of the test case to the requirement Ensures preexecuted test protocol has the necessary test data requirements to run the tests Reviews postexecuted 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.
Employment Type
Full Time
