Job Title - CSV Engineer
Location- Raritan, NJ(Onsite)
Role Descriptions:
Demonstratable Experience in Computer System Validation (CSV)Experience in software development processes (SDLC) and software testing life cycle (STLC)
Experience in drafting reviewing revising and maintaining validation documents (CSV) including Compliance Analysis Compliance Plan Change Control Document User Functional Requirement documents Risk Assessments (Risk Register) Test (STUATRegression) Protocol Test Defect Report Test Summary Report Compliance Summary Report Traceability Matrix Hypercare Plan Operation Run Book and other validation technical documentation.
Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI)Strong knowledge of JIRA HP-ALM qTest tools
Knowledge of validation testing in projects implemented using agile methodology
Knowledge about Agile techniques like User Stories Continuous Testing tasks etc.
Ability to take and understand the commitment to deliver the product on time.GxP experience is required
Experience of validation support for 21 CFR Part 11 implementation in Pharma industries.
Experience working within a FDA
Other regulated pharma industry.
Meeting with system users to understand the scope of projects
Participating in business requirement discussions to draft SDLC CSV Qualification documents.
Developing validationqualificationmigrationverification strategies for softwareExecuting validationqualificationverificationmigration strategies per quality assurance SOPs..Providing validationverificationqualification recommendations to stake holders as necessary.Managing relationships with customers technical team quality assurance team testing team and other stake holders to ensure the validation verificationqualification solution delivered to the customer meets expectations.
Ensuring SDLCCSV
Qualification activities are conducted as planned
Generate review and Computerized Systems lifecycle documentation including risk and impact assessments user requirement specifications functional specifications traceability matrices qualification protocols validation plans and validation summary reports etc.
Working towards project deadlines
Communicating findings to technical and non-technical colleagues.
Liaising with project teams in other parts of the world
Leading the validation effort.
Strong verbal and written communication skills with the ability to liaise with a variety of stakeholders
Must be self-motivated and pro-active
Need to show constant dynamism and able to manage pressure.
Attention to detail
Competent CSV skills
The ability to work in a team and individually
Organizational skills with the capability of working towards tight deadlines
Able to work with demanding customer
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