Validation Documentation Specialist

4 days ago


Bengaluru, India QAAgility Technologies Full time

Job Title- Validation Documentation Specialist


Job Location- Onsite (Bengaluru)


Experience- 6+ years


Mandatory Skills:

  • Validation Responsible/Documentation Writer
  • Microsoft Power technologies
  • Experience in category 5 (Customized IT solution) solution implementation.
  • Experience writing end to end documentation for IT solutions implementation especially for category 5.
  • Understand the term GxP and worked with GxP Systems and Non-GxP systems.
  • Concept of risk assessment in the implementation and operation of IT solutions.
  • Understand Deviation, how to perform its investigation and propose CAPA for the deviation.
  • Handled change management or are you aware of writing change requests.
  • Performed periodic review for the IT solution.
  • Review and approve/ acknowledge (on behalf of NN QA) validation deliverables including Installation Verification (IV), Operational Verification (OV), Performance Verification (PV) etc.


Optional Skills: (Good to Have Skills)

  • Knowledge of PowerApps technologies, Experience in working with Pharma industry client’s
  • Experience of working with validation tools such as ADO.
  • Experience of handling implementations using Agile framework.


Roles & Responsibilities:

  • Concept of risk assessment in the implementation and operation of IT solutions.
  • Understand Deviation, how to perform its investigation and propose CAPA for the deviation.
  • Handled change management or are you aware of writing change requests.
  • Performed periodic review for the IT solution.
  • Experience of working with validation tools such as ADO.
  • Experience of handling implementations using Agile framework.
  • Review and approve/ acknowledge (on behalf of NN QA) validation deliverables including Installation Verification (IV), Operational Verification (OV), Performance Verification (PV) etc.



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