Live opening · Posted 5 days ago
At a glance
The key details from the original listing.
About the role
Description supplied by the original job listing.
About the Role
Responsibilities
Strong hands-on knowledge of Computer System Validation (CSV) in a GxP-regulated manufacturing environment
Experience with manufacturing equipment and associated computerized systems, including PLC, SCADA, HMI/IPC and shop-floor applications
Experience in validation and qualification activities such as Risk Assessment, IQ, OQ, PQ, Traceability Matrix and Validation Summary Reports
Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 and Data Integrity
Exposure to digital manufacturing platforms / digitalization/AI initiatives and integration of shop-floor systems with enterprise applications
Understanding of LIMS, QMS, MES and other GxP applications
Experience supporting change controls, deviations, CAPA and regulatory audits
Ability to work effectively with Manufacturing, Engineering, Quality, IT, Automation and equipment vendors
Professionals with a strong combination of CSV + Manufacturing Equipment + Digital Platforms are encouraged
Qualifications
B. Tech
Preferred Skills
Professionals with a strong combination of CSV + Manufacturing Equipment + Digital Platforms are encouraged
Pay range and compensation package
up to 8 LPA
Work arrangement
No
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