Job Description

Technical/Functional 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

Experience Required
•Knowledge of Pharmaceutical/Biotech manufacturing processes and/or manufacturing systems
•Excellent communication skills with strong command over written and spoken English.

Roles & Responsibilities
•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.
•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

Generic Managerial Skills
•Resource should be quick learner and self-driven; capable of working with client partners to meet strategic Objectives
•Resource must be able to identify, mentor and hone talent to build leaders from within a team.

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