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Software Validation Lead
Ref No.: 17-00274
Location: Pittsburgh, Pennsylvania
Position Type:Contract
Start Date: 07/03/2017
Project Overview: SAP S4/HANA is being implemented to manage inventory only for external customers. Additional custom User Interfaces are being created to integrate into SAP to provide a user friendly experience. (desktop, mobile app, vending machine, scanners and kiosks)

Role Scope / Deliverables: Validation Lead
  • Provide guidance, leadership and all key validation deliverables to successfully validate the entire software package.
  • Responsible to define Software Validation Approach in accordance with Gamp 5 standards and pro-actively educate the team. (Our Scientific Client has not validated any software prior)
  • Responsible to develop the Validation Project Plan in conjunction with the overall program plan -
  • Work continuously with Program Manager and each work stream to ensure execution to plan, compliance of documentation and timely sign offs of all key documents
  • Responsible to provide leadership and guidance in the effort to Validate key suppliers
  • Responsible to work closely with Test and QA divisions to ensure compliance and mitigate risk
  • Responsible to develop or assist in developing key validation documents, Risk Assessment, Validation Plan, Data Migration Plan, Testing Plans, Requirement sign offs, etc
  • Responsible to maintain the documents in the appropriate systems (Master Control. Client ALM)
  • Responsible to report status on overall effort for each work stream to leadership team
  • Responsible to assist in requirement review meetings to help determine GxP vs non-GxP requirements and to ensure wording is best suited to testing.
  • Responsible, in conjunction with the Program Manager, to identify personnel for key roles (Business Owner, System Owner, IT BA, etc)
  • Responsible to ensure all key approvers are trained/certified for their respective roles (either in Master Control or Client ALM) in a timely fashion
  • Responsible to work closely with QA training leads to identify and schedule appropriate training's for key approvers
  • Responsible for identifying, mitigating and when necessary escalating risks to Program Manager and Program Leadership

Key Skills:
  • Experienced in Software Validation - GAMP 5 (pharma or medical device experience preferred)
  • Experience validating SAP, preferred
  • Must have strong leadership skills
  • Must be able to work independently
  • Experience with Master Control and Client ALM desired
  • Excellent written and oral communications skills are a must
  • Excellent presentation skills
  • MS Project/ Office365 skills are a must
  • Functional with some technical understanding of SAP preferred
  • Must be well versed in best practices concerning Software Validation
  • Prefer experience in validating SAP, custom software,
  • Must know what to do, how to do it, execute to plan.