Northbrook, Illinois
Manager/Senior Manager ITQA (Apple Project) Job Opening in Northbrook, Illinois - ***PHARMA EXPERIENCE IS MUST***
OBJECTIVES:
ITQA Support/backfill for Apple Project.
Ensure SDLC/CSV is followed for Apple Project ? GxP aspects of the Global SAP Platform (system/application), the required infrastructure, the associated tools (eg Solution manager, test management, training) and GxP interfaces
Provide QA review/approval of CSV/SDLC deliverables in a timely manner
Participate in Apple project meetings and provide the necessary input/feedback, and/or elevate issues to the ITQA lead for the Apple Project as necessary
Assess any new vendors/service providers, or any changes to the scope of services provided by existing vendors/service providers
Provide backfill for ITQA projects
EXPERIENCE:
At least 5 years experience on the Pharmaceutical Industry
Significant experience in an ITQA role
Experience of SAP/ERP system validation activities
Experience supporting GxP systems used by pharmaceutical commercial operations
High level of commercial acumen; high level of business integrity with solid pharmaceutical industry experience in a market access/commercial role ideally at a pan-European or global level
Familiarity with terms and techniques associated with SDLC/CSV, including Good Automated Manufacturing Practice (GAMP5)
Experience of working in a project team at a pan-European or global level advantageous
Experience of working with external consultants an advantage
SKILLS:
Qualifications Relevant University degree, or equivalent
Knowledge/Skills Knowledge of SAP ERP system validation Knowledge of EU, US and JP GxP requirements in Pharmaceutical Industry Highly organised; good personal planning to manage workload to strict deadlines High attention to detail Perseverance, results oriented finisher Auditing of service providers advantageous
Languages English - excellent spoken and written
Computer Literate Competent with etc and able to tackle new systems with confidence
Customer Focus Continuously thinking and acting from the customer's perspective and inspiring the team to do so Able to navigate around organisational barriers so that the project, and resulting systems are managed in compliance with the SDLC, CSV requirements and GxP
Strategic Orientation Able to integrate the strategy for PJ Apple with that of other parts of the business from the business SMEs
Job Type: Contract
Salary: $80.00 to $85.00 /hour
Required experience:
Pharmaceutical industry: 5 years
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