CSV (Computer System Validation)

CGxPServe

Posted on : 14-06-2025

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1 Vacancy

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Job Location

Indianapolis, IN - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 14-06-2025

Job Description

Roles & Responsibilities:

Candidate must have understating on latest regulations i.e. 21CFR Part 11 EU annex 11 and Guidelines e.g. GAMP5 guide.
Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
Well versed with Manufacturing Quality and engineering system and their validations.
Knowledge of Pharmaceutical / Life Sciences as domain.
OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus).
Experience to MES QMS (Track wise) Lab solutions i.e. LIMS Empower CDS Chrome L on Business Analytics Middle wares etc. will be an advantage.
Client/DCS Qualification.
ISA95 High level of understanding.
OT Security will be a plus.
Standalone Systems Qualifications.
Client/DCS Integrated with Manufacturing Equipment qualification.
Stakeholder management and good executor with required communication.

Employment Type

Full Time

Company Industry

Key Skills

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About Company

CGxPServe

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