IT Validation Lead - Chicago Area

Due to a constant growth, PQE Group is now looking for a IT Validation Lead in the area of Chicago, IL to work in Pharmaceutical Industries.

Main Responsibilities include, but are not limited to the following:

  • Coordinate with Core Team and maintain/guarantee the documentation/validation strategy defined.
  • Support and coordinate documentation/validation and training activities with project core and site members
  • Managing multi-sites documentation alignment team
  • Coordination of validation activities and deliverables against an agreed  project gantt
  • Ability to detect any possible issue in advance and to define possible mitigation actions per time, in collaboration with Core Team
  • Ability to integrate in an on-going structure, understand processes and way of work, and to teach to the team
  • Deliverables Creation (e.g. presentation, reports, project/validation documentation)
  • Resources Planning according to the agreed budget and milestones to be achieved – ability to detect budget issues per time and to document/report in adequate manner
  • Support authors activities planning e.g. documentation amendment, progress reporting, training, etc.
  • Routine and on-demand reporting to program site/core alignments
  • Experience in HR – optional

Required Qualifications:

  • 10+ years of experience in Life Science / Pharmaceutical Sector
  • Ability to manage and/or coordinate projects from start to completion in Quality Compliance field
  • Knowledge in Documentation Life Cycle and Good Documentation Practices
  • Familiarity with GMP regulations and relevant record management
  • Experience in Pharma computerized systems i.e. HPALM, EDMS, TrackWise, Documentation systems, etc
  • Knowledge in ERP processes in Pharma (SAP ERP huge advantage), and strong experience in ERP (SAP) implementation/validation complex projects (multisites implementation)
  • Advanced MS-Office (Excel, MS-Project, PP)
  • Demonstrated leadership skills change management and risk/crisis management
  • Strong written, oral & presentation skills
  • Good communication skills
  • Able to work in changing dynamic environment
  • Degree in Technical Field
  • US Resident / Work permit visa (Chicago)
  • Driving license required
  • Fluent English

Skills:

  • Never worked directly or indirectly with the customer for which he/she will work
  • Mature, secure, very open-mind with strong knowledge in complex SAP multisites programs – but never appear overconfident and conceited
  • Ability to interact with other person, internally and at customer site, with different attitudes, but always in a kind, professional an polite way
  • Respect in Roles and reporting
  • Great availability to overwork, under pressure and stress and to convince the team to do as well for the common goal of the project
Business units
Information Technology
Locations
United States
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