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Open nowFirst seen 37 hours ago

SAP Validation Project Manager

RxCloud86 open roles

Where
California City, CA, United States
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Your applicationOpen nowSAP Validation Project ManagerRxCloud · California City, CA, United States

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on RxCloud's own form.

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The clock on this job

Early applications get read.

11.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.9%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: first seen 37 hours ago

The posting

Job Requirements:

  • Coordinate the GxP validation activities amongst the validation and functional/ technical team members
  • Prepare and maintain the project plan for validation function based on overall project plan
  • Track and report the status of the Validation activities against the project plan
  • Organize validation related activities and deliverables in accordance with the project timelines.
  • Make sure individual validation activities are aligned with the strategic direction of the program Develop an evaluation method to assess the validation workstream strengths and identify areas for improvement
  • Manage Global project teams with a diverse array of Vendors, talents, and responsibilities Engage stakeholders to align validation workstream priorities, coordinate interdependencies, and navigate risks
  • Manage changes and intervene as needed to ensure project goals are achieved
  • Meet with stakeholders to make communication easy and transparent regarding project issues and decisions on services
  • Produce accurate and timely reporting of validation workstream status throughout the implementation (multiple releases)
  • Analyze program risks and update RAID log accordingly

Skills:

  • Project management
  • Excellent communication (oral and written) and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
  • Knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11
  • knowledge of computer system validation and GAMP -5 standards

Deliverables:

  • Stakeholders register
  • Risk & Issues (RAID) Log
  • Program Communications Management Plan
  • Program Weekly/Monthly Status report
  • Meeting Notes I Action Items post every meeting
  • Project Change Request / Change Order if any v111. Go-Live Sign Off/ Final Project Acceptance
  • Lessons Learnt document
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