| Role name: | Lead |
|---|---|
| Role Description: | • Work in partnership with the Global IT team and site representatives to understand business needs and implement innovative solutions to add value to the site while maintaining computer systems in a validated state.• Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX• Periodic Review of PMX- March and Oct.• DI Documentation Project- Update security plans and any other documentation |
| Competencies: | Life Sciences : Computer System Validation, Healthcare : Pharmacy, Communication, Regulatory IT Compliance |
| Experience (Years): | 8-10 |
| Essential Skills: | • Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX• Periodic Review of PMX- March and Oct.• DI Documentation Project- Update security plans and any other documentation.• SIA of LQPs and other Global documents.• ARR for the computer systems.• Assist with any CSV project in the Compliance Map as needed.• Periodic review of CVM and DSA |
| Desirable Skills: | ? Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.? Experience of working in virtual teams across different cultures and geographies ? Experience of working with cloud-based technologies is desired |
Mohd Adil | Talent Acquisition
2838 E. LONG LAKE ROAD SUITE 210, TROY, MI 48085
M: 469-552-7783 | Mail: [email protected]
Connect me on – Linkedin
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