Validation Documentation Specialist
2 days ago
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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