Compliance Lead

Position: Compliance Lead Location: KOP PA-Hybrid Duration: 1 Years Phone & Skype Immediate Interview Skill Rating Mandatory Skills Hands on experience in Years Last used -Year Self-Rating (Scale 1-10) 1. CSV
2. SAP Validation
3. DSCSA
4. Manufacturing
Keywords
CSV, Computer System Validation, SAP Validation, Product Serialization, DSCSA


Roles and Responsibilities
- 10years' Experience in Validating SAP systems in Manufacturing
- Experienced in CSV activities in Manufacturing 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
- Reviews - 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