CSV - Compliance and Validation Testing Lead

Job Title: Compliance Lead

Contract Duration: 6 months, extendable

Location: King of Prussia, Pennsylvania.

Working model: Onsite/Hybrid

Required Skills: CSV, SAP Validation, Product Serialization, DSCSA

Roles and Responsibilities:

Perform review for GxP systems to ensure compliance with regulatory requirements

Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology

Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria, and ensuring 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 to participate in the defect management process

Able to author a validation plan, compile a validation summary report, and generate 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

Qualifications:

10 years’ Experience in Validating SAP systems in Manufacturing

Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, and MES systems

Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis

Prior experience in using tools like ALM, DMS and JIRA

It is good to have experience in implementing US-DSCSA

Bachelor’s degree in Computer Science, Information Technology, or a related field.

Certification in CSV, SAP, or related fields is highly desirable.

Excellent communication and interpersonal skills.

Strong analytical and problem-solving abilities.

Ability to work independently and in a team environment.