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lims developer

3 months ago

Pune, Maharashtra, India CIEL HR Services Full time

Role - LIMS Developer

Experience - 7+ years

Location - Bangalore (Preferred)

Skills - LIMS , EMPOWERMENT CDS , 21CFR Part 11 and GxP , SOPs

Roles and Responsibilities

  • Strong Technical Knowledge on Empower3 FR5 & other CDS Systems
  • Maintaining and supporting current CDS system
  • End user issue support, troubleshooting, & resolution
  • Administration of CDS system and server maintenance
  • Backup, archival, restore and periodic review of system
  • LACE support
  • Project Management / Archival
  • Ensures and maintains security and appropriate controls.
  • Evaluates policies procedures and standards for quality systems.
  • Proposes and participates in the implementation of enhancements that improve systems and provide enhanced compliance.
  • Support in deployment/Installation of CDS applications
  • Complete knowledge on user management of lab applications
  • Coordinate with multiple instrument vendor during application/instrument setup and instrument qualification
  • Hand-holds Site SME's in Empower operations and implementations through proper training and support
  • Experience working in a Pharmaceuticals, Chemical, Manufacturing or any regulated environment....
  • Excellent verbal and written communications skills
  • Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment, and execution of validation protocols
  • Data integrity and compliance to 21CFR Part 11 and GxP standards
  • Prepare draft and final SOPs and compliance documents