Offer summary

Qualifications:

10+ years of experience in validating systems and CSV activities in GxP applications., Strong knowledge of Agile and Waterfall methodologies for software development., Experience with tools like ALM, DMS, and JIRA., Familiarity with US-DSCSA implementation is a plus..

Key responsabilities:

Review GxP systems to ensure compliance with regulatory requirements.

Author Validation Plans and compile Validation Summary Reports.

Act as a single point of contact for system assurance and compliance services.

Build and manage relationships with regional stakeholders and guide the team on deliverables.

Job description

Role Name: CSV Lead

Location: New Jersey, NJ (Remote)

Duration: Contract

Job Description

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 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 "

Thanks & Regards

4365 Route 1 South, Suite 105

Princeton, NJ 08540

Bhavesh Sharma

609-766-0092

bhavesh@applabsystems.com

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