Qualification required:

 B. Tech in Electronic & Instrumentation, B.E. in Instrumentation & Control, BCA, or MCA.

Ø  Technical skills required:

·      Sound knowledge of Automation projects e. g. L2 integration, MES, SCADA, eBMR, LIMS.

·      Sound knowledge of QC and Manufacturing software.

·      Sound knowledge of GAMP.

·      Sound knowledge of 21 CFR part 11.

·      Sound knowledge of Annex 11.

·      Sound knowledge of data integrity related to IT systems.

 Ø  Job Description:

·      To Prepare and implement computerized system validation (CSV) procedure in coordination with stakeholder.

·      Implementation of various IT-based projects (e.g., LIMS, eBMR, CDS, and QMS, SCADA.).

·      Defining validation strategies and executing the validation lifecycle documentation.

·      To carry out Periodic reviews of GxP Computerized Equipment to meet regulatory requirements.

·      To carry out regular audits of various GxP Computerized and IT System used.

·      Provide Computer system validation and documentation support during regulatory inspections.

Budget: up to 7 L/A