Documentation Writer validation gxp

2 weeks ago

Bengaluru Karnataka, India 7N Full time

**Mandatory Skills**:

- 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.

**About 7N**:
Over decades, 7N has been part of several waves of digitalization. Today, our consultants work across industries and geographical borders to deliver the projects that define the new digital realities. We offer a highly specialized portfolio of IT services and solutions delivered by the top 3% of IT professionals. Our expertise spans across many industries, providing digital transformation across all phases of the IT project life cycle.

By engaging early with 7N, you benefit from our experience and expertise when defining the project scope and strategic needs, and you gain flexibility to accommodate changing demands while maintaining control and ownership of IT development.

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