Job Summary

This role acts as Independent Quality reviewer and approver of Computer Software Validation documentation. As a member of the Digital Quality Assurance team, this role works closely with the Project team and the Validation team to ensure West procedural and regulatory requirements are met throughout the Computer System lifecycle of GxP Computer systems.

Essential Duties and Responsibilities

- Oversee GxP projects assigned and ensure all the computer system Validation activities are in line with West QMS and regulatory requirements.
- Review and approve Computer System Validation lifecycle documents.
- Provide inputs during GxP assessment and Risk assessment from QA perspective.
- Participation in projects meeting and provide guidance to project team and Validation team towards CSV activities.
- Follows West procedures on Computer System Validation, supports the validation of GxP software and process improvements to software.
- Works closely with Project team to document regulatory requirements for GxP applications.
- Reviews Test Protocols/evidence, executions and execution deviations as applicable.
- Review and approve Computer software change control documentation.
- Provide training to Digital & Transformation team on CSV process.
- Assist the Digital QA lead during Internal/External audits on the QMS documentation.
- Involve,



preparation, review and approval in documentation related to Digital quality.
- Assist in CSV procedure/work instruction creation, review and approval.
- Participation in Global quality events.

Education

- Education: Batchelor or master’s degree in science related field, or Information Technology

Work Experience

- Experience: 3-6 years

Preferred Knowledge, Skills and Abilities

- Regulatory requirements for ERES like FDA 21 CFR Part 11, Eu Annexure 11 etc.,
- End to End Computer System Validation process.
- Risk Management
- Exposure to Computer Software Assurance approach
- Agile and Waterfall Methodology
- Ability to work in a team setting and under guidance.
- Audit process
- Incident, Deviation and CAPA process knowledge
- Exposure to AI based Computer Systems.
- Periodic review

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Shift

- Prefer 12pm – 9pm India time. Willingness to work outside of these hours as needed.

📌 Analyst - Digital Quality (India)
🏢 West Pharmaceutical Services
📍 India