Requirements :
In depth knowledge of IT & Process Automation requirements for Life Sciences & good understanding of Systems Validation as per GAMP5 & 21 CFR Part 11
10-15 years of Experience in Manufacturing Domain & Plant Automation with expertise on platforms for Databases, SCADA, Historian, Batch & PLC Software, MES through-out the LifeCycle starting from Design to Operations & Retirement.
Accountabilities :
Spearhead all IT initiatives in the area of Manufacturing and Quality.
Process Control & Data Archival / Integration
SAP / Manufacturing System Integration
Dashboards - Support Quality Management, Analytics and performance measurement for business Critical KPIs
Ensure all the IT systems are implemented / Qualified according to the CGMP, GXP, QMS, global quality standards and in compliance with regulations (21 CFR, ISA 88 / 95..)
Implement data security, backup procedures to ensure integrity of all data in systems
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