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Computer System Validation Engineer

ICS{ Instrumentation And Control Solution }

Nagpur, Maharashtra, India · 全职

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经验
2-5岁
薪水
职位空缺
1
发布
2小时前
工作模式
在办公室
合格
Candidates with 2 to 5 years of experience in computer system validation who can join within an immediate to 30-day notice period.
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职位描述

Overview

ICS (Instrumentation And Control Solution) is expanding its team and looking for CSV Validation Engineers who have 2 to 5 years of relevant experience. This position is based across multiple locations, including Pune, Nagpur, Goa, Mandideep, Pithampur, and Nashik.

Role Summary

The selected professional will take ownership of computer system validation activities for manufacturing and quality control environments, ensuring that systems and documentation meet pharma regulatory expectations.

Responsibilities

  • Carry out complete computer system validation for manufacturing and QC systems from start to finish.
  • Prepare and execute URS, IQ, OQ, and PQ documents and protocols.
  • Manage validation work independently with minimal supervision.
  • Maintain adherence to GAMP 5, 21 CFR Part 11, and data integrity requirements.

Requirements

  • 2 to 5 years of experience in CSV validation work.
  • Practical knowledge of computer system validation concepts and execution.
  • Understanding of data integrity expectations and compliance standards.
  • Working knowledge of 21 CFR Part 11 and GAMP 5.
  • Experience with pharmaceutical guidelines and regulatory compliance.
  • Ability to prepare and execute URS, IQ, OQ, and PQ protocols.
  • Strong documentation skills.

Additional Information

Notice period: Immediate to 30 days.

Locations: Pune, Nagpur, Goa, Mandideep, Pithampur, and Nashik.

Contact: Shanu Pandita, recruitment@ics-india.co.in, 9109188946.

Note: Applicants should share an updated resume for consideration.

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