My Summary:

The client is in need of multiple SAP Validation resources with specific skills related to validation of regulated systems. This roles need candidates with software validation experience particulry in the GxP environment.

  • Location: Central New Jersey
  • 5+ years validation experience in the Life Science
  • Duration: 6-month with possible extension
  • Prior SAP, HP ALM and eQMS experience is a PLUS.
  • Resource must be able start immediately preferably August 12 or 19.
  • If they receive the resume and screen the candidate, onsite in-person interview will be scheduled early next week.

Roles and Responsibilities

  • Author, review and execute validation documents (validation plan, requirements, test plans, data migration plan, test scripts, test summary, traceability matrix).
  • Support creation of regulatory risk assessment, data integrity assessment, and periodic review.
  • Work directly with the clients onsite or offsite supporting multiple clients projects
  • Qualifications
  • Bachelor's degree in Computers Science or related field
  • Hands-on working experience with Electronic Quality Management System (QMS) using TrackWise, SAP QM, and/or VeeVa platform
  • 5+ years of experience in technical writing, test scripts/cases authoring and execution.
  • 5+ years of experience working on projects related to Pharmaceutical or Life Sciences domain in IT software mplementation.
  • Experienced in preparing and executing validation documents in alignment with client-based CSV, SDLC and Change Management SOP s.
  • Knowledge on industry software testing tools (i.e. HPQC, HP ALS, JIRA, etc.) is a plus.
  • Understanding of GxP regulations and computerized system validation methodologies.
  • Strong validation skills with demonstrated knowledge within the areas of computerized system validation and quality assurance
  • Prior SAP, HP ALM and eQMS experience is a PLUS.
  • Excellent communication (verbal and written), teamwork, and organizational skills
  • Ability to develop and meet project schedules, along with contingency plans
  • Detail Oriented
  • Ability to work as a team player. Results driven, follows through, ability to work effectively at all levels within the organization, with customers and with partners.
  • Comfortable working in a fast paced team environment
  • Other duties as assigned
- provided by Dice
Associated topics: business, business intelligence, client, consult, consultant, crm, information technology consultant, market, marketing, sap

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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