Job Description

Title: ERP Technical Analyst with Pharma

Type of role: 12+ Months - Contract
Client Location: San Francisco, CA (Remote0

***** Must have previous experience in a Pharmaceutical or Biotech domain.*****

Our end client is seeking a results-oriented ERP Technical Analyst consultant to support and lead a NetSuite ERP project in a fast-paced drug discovery environment.

Previous experience with ERP is essential. NetSuite is preferred, other ERP suites (Oracle, SAP etc. will suffice)

Essential Duties and Responsibilities
  • Responsibilities include providing technical support, and training for the NetSuite - Supply Chain module implemented by our customer, managing application configuration, developing and maintain system metrics, and participating in any necessary computer validation testing.
  • Develop application business requirements and systems goals in collaboration with the business community and IT applications specialists.
  • Work with the head of GxP Enterprise applications to manage validation programs for applications as required by 21 CFR Part 11 compliance.
  • Develop documentation and business requirements for workflows as required by the business community and by 21 CFR Part 11 compliance.
  • Plan and communicate application upgrades, maintenance fixes, and vendor-initiated patches.
  • Develop and manage the change control process for Clinical, QA, Regulatory, and Biometrics initiatives which have agency regulated requirements.
  • Ensure that new software integrations meet business requirements, system compliance, testing, validation, and interface specifications.
  • Manage all business group enhancement and upgrade requests for managed products.

Professional Experience:
  • 5+ years direct experience managing R&D applications and/or systems management with a focus on Clinical Development, Regulatory and Research systems in a pharmaceutical industry.
  • Proven experience in overseeing the direction, planning, installation, and implementation of software solutions. Direct, hands-on experience with server administration tools.
  • Strong knowledge of authoring and maintaining computer system validation documentation.
  • Knowledge and experience in working within GxP or regulated environment and within an SDLC framework.
  • Knowledge of applicable data privacy practices and laws
  • Knowledge of 21 CFR Part 11 and Annex 11 regulations
  • Bachelor’s degree in information technology, Business Systems, or Computer Science

Application Instructions

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