Computer System Validation (CSV) Raritan, NJ
ramashish kumar
Hi,
Kindly share your updated resume if you are good with below JD. I will be happy to share more information.
Computer System Validation (CSV)
Location: Raritan, NJ
Duration: 6+ months
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 validation/qualification/migration/verification strategies for
softwareExecuting validation/qualification/verification/migration strategies
per quality assurance SOPs..Providing validation/verification/qualification
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 verification/qualification 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
Essential Skills: Validation Lead with AI knowledge
Desirable Skills:
Keyword:
Skills: Software Product Development~Life Sciences : Computer System Validation
Experience Required: 10 & Above
Thanks and Regards
Ramashish Kumar
Valzo Soft Solutions LLP
A: 12600 Deerfield Parkway ,
Suite -2123, Alpharetta, GA-30004
LinkedIn : linkedin.com/in/ramashishkumar86