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Job Details

ID #19265533
State Pennsylvania
City Kingofprussia
Job type Permanent
Salary USD TBD TBD
Source CSI Tech
Showed 2021-09-06
Date 2021-09-05
Deadline 2021-11-04
Category Internet engineering
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SAP Systems/Validation Analyst

Pennsylvania, Kingofprussia, 19406 Kingofprussia USA

Vacancy expired!

This position reports to: Associate Director Digital Quality in King of Prussia, PA

Role Summary:The SAP validation analyst is to support the company's SAP and other systems as assigned. The analyst will work closely with the various sites under the direction of the Digital Quality (DQ) lead to validate and/or qualify SAP and other computerized systems and support their operation and maintain the systems' validated state. The validation activities will be performed according to the system's risk profile while meeting regulatory requirements and the requirements of the Company's Quality Management System (QMS).

Essential Qualifications/Experience: BS degree in a computer-based discipline (e.g. Computer Science, Information Systems) or a technical discipline (e.g. Engineering, Mathematics) or equivalent combination. Experienced with SAP system validation Minimum five (5) years related experience in a regulated, preferably pharmaceutical, industry. Strong communication skills (written and verbal)

Essential Skills, Competencies, Knowledge and Attributes:
  • Must have knowledge of FDA's Code of Federal Regulation related to Quality Systems (e.g. 21CFR Part 11, Part 280, Annex 11, ICH 8 and 9) Regulations that govern validated computer software applications.
  • Experience with the following software applications: SAP ERP, SAP MDG, UiPath, QlikSense
  • Above average MS Office (Word, Xls, PPT) skills
  • Good written and verbal communication skills
  • Good time management and organizing skills
  • Must be able to work independently and with project teams
  • Knowledge of document management systems and the various change control systems, including ChARM is a plus
  • Understanding and experience with GAMP5 methodology is preferred.

Responsibilities:
  • Per DQ's guidance the analyst will participate in project team activities with respect to the validation of new and existing SAP and other computerized systems, including GxP and non-GxP systems.
  • Participate, as requested, in initial and/or functional risk assessments with respect to GxP relevant regulations.
  • Authors and/or participate in authoring of validation plans and reports in line with regulatory expectations/requirements, as applicable, and in alignment with the QMS.
  • Ensures that system relevant technical documents are created/updated in a timely manner in accordance with the project and/or validation plans.
  • Completes the validation review of GxP relevant test cases (pre and post execution), as requested.
  • Participate in User Acceptance Testing to ensure the business requirements are fully met.
  • Supports the SAP systems/ operational phase's change control and small projects

Job Environment
    • The position is located in King of Prussia. Will consider fully remote for the right candidate.
    • Member of the Digital Quality department
    • Travel requirements: none

#ZR-Tech

Vacancy expired!

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