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Lims+ Empower

2 weeks ago

Bengaluru, India CIEL HR Services Full time

**LIMS + Empower**

**Location - Bangalore/Pune**

**Notice - Immediate to 15 days**

**Experience - 7 + years**

**Key skills -**
- 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.
- 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