System Assurance Lead

Position : System Assurance Lead

Location : KOP PA

• Onsite

Duration : 1 Years

Mandatory Skills

CSV Compliance and Assurance services LIFE-SCIENCES Biotech (GXP FDA CSV IQ / OQ / PQ) Veeva I Innovation Defect Tracking Tools JIRA

JD

Primary Skill- Computer System Validation Computer system assurance GAMP GxP risk assessments Change Management Communication and Organization.

Secondary Skill- JIRA Veeva Agile and Waterfall methodology

10 years Experience in validating systems and experienced in CSV activities in GxP-related applications such as LIMS Custom Application AI and Innovative tools with 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

Key Skills

Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

Employment Type : Full Time

Experience : years

Vacancy : 1