Executive – IT

Job Summary

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)