Executive – IT

4 years

4 Lacs

Posted:2 days ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Summary

We are looking for an experienced professional to manage and validate GxP computerized systems in a regulated pharmaceutical environment. The ideal candidate will play a key role in ensuring IT compliance with industry regulations and supporting core Quality Management System activities.

Key Responsibilities

  • Installation and configuration of operating systems and other applications
  • Diagnosing and troubleshooting of computer system and software problems
  • Maintain an inventory of GxP computerized systems.
  • Preparation and implementation of all the IT procedures as per GMP requirements.
  • Responsible for Electronic data backup, archival and restoration.
  • Verification of daily backup for electronic data generated for instruments.
  • User management (Creation / modification of User IDs and passwords, assigning privileges) for laboratory and GMP Softwares.
  • Developing the validation deliverables for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems)
  • Preparation, execution and reporting of GxP computerized systems validation deliverables
  • Maintain the validated state of all GxP computerized systems
  • Conduct periodic reviews of all GxP computerized systems to ensure continued compliance.
  • Manage QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs.
  • Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance.
  • Good knowledge of GMP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity requirements for Pharma

Required Skills & Experience

  • 3–4 years in Pharma industry
  • Strong working knowledge of GMP, 21 CFR Part 11, Annex 11, and GAMP 5
  • Hands-on experience in validation of GxP systems within a pharma or life sciences setup
  • Solid understanding of pharmaceutical regulatory and compliance frameworks

Educational Qualification

  • M.Sc / B.E / B.Tech / MCA (with relevant industry experience)
Skills: gamp 5,user management,annex 11,computerized systems,data integrity,it compliance,qms activities,gmp,csv,21 cfr part 11,gxp systems validation,electronic data backup

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