Manager-Quality Informatics

Hi,

We are having an opening for Manager- Quality Informatics in our IT department at Halol location.

Job Summary :

Quality Control GxP Systems - Chromatographic & Non chromatographic systems, Data backup, User management, system software trouble shoot (L1), Computer system validation, Regulatory & Customer audits and compliance, QMS related IT (like Change control, Deviation, Investigation) etc.

Areas Of Responsibility :

• Perform in-house software validation, re-validation of computerized systems of QC Lab and Micro area.
• Initiate and prepare active user list for Laboratory systems & Perform periodic access right and security policy review for Laboratory systems.
• Implementation of security policies as per site and global procedure.
• Perform administration activities as per procedure for computerized systems and instruments.
• Preparation of data backup and restoration procedures.
• Execution of manual backup and restoration in lab applications as per procedure.
• Coordinate with Corporate QA IT and QA department for implementation of Global Procedure.
• Prepare the SOP/CSAP for Lab computerized systems.
• Updation of roles and privileges as per business owner requirements and to perform validation related activity.
• Support Infra-IT activities.
• Authorized to review/ Signoff the documents related to the Quality informatics systems.
• Knowledge of Empower, Chromeleon, LABX, ICDAS, Lab Solutions.
• To perform QMS related activity.

Educational Qualification :

Diploma IT, BE IT, Computer Science

Experience :

12 + Years