Job Description :
There will be F2F Client Interview if in NJ.

Job Description for the new position:

Apply your expert knowledge of 21CFR Pt. 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical and other GxP and GAMP regulated environments
Knowledge of AL tools such as HP ALM and JIRA.
Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications
Share best practices, industry knowledge, and personal expertise to educate both clients and fellow consultants, in formal and ad hoc settings
Proven capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management.

Detailed JD on day to day activities:

·         Responsible for Compliance Plan and Compliance report delivery and also track status of deliverables agreed in Plan.

·         Provide team with templates from latest SDLC Version

·         Following listed Deliverables will be reviewed and approved by Q-CSV:         

o    Author, Review and approve Compliance Analysis document to ensure any updates required

o    Risk Assessment for all new User requirements

o    Review Impact assessment for any new features released

o    Review Architecture Design

o    Ensure IAAP and Security Standard Configuration documents are updated if needed

o    Review Business Impact document

o    Ensure and review Infrastructure deliverables for any updates

o    Ensure all SOP/WIs are updated for any changes related

o    Author, Review and approve Compliance Plan

o    Review  and approve User Requirements Specification for any new and for any updates required

o    Review & approve Functional Requirements Specification

o    Review & approve System/UAT Test Protocols

o    Review & approve System/UAT Test Scripts ( Pre and Post Review)

o    Review & approve Test Defects

o    Review & approve Master Requirement Traceability Matrix

o    Review & approve System/UAT Test Reports

o    Author, Review & approve Compliance Report

o    Review Hyper care transition plan and Production readiness documents

o    Review & approve QA Change Request for implementation

o    Review & approve QA Change Request for Closure

o    Review & approve PROD Change Request for implementation

o    Review & approve PROD Change Request for Closure

·         Raise Observation or Non Conformance as applicable

·         Escalate Risk and issues as identified through the project lifecycle