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Project Manager, QA GxP CSV

  • Job type: Permanent
  • Location: Columbus, Ohio
  • Salary: Negotiable
  • Job reference: 300083/001_1529012644
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 14/06/2018

Project Manager, QA GxP CSV required for Mid-Sized Bio-Pharmaceutical Company

  • Project Manager, QA GxP CSV

  • Columbus, OH Area


A rapidly expanding, Quality oriented Bio-Pharma, specializing in combination products in the areas of sterile injectables and bone regeneration materials, is actively looking to speak with process-oriented CSV professionals to ensure the company's GxP Computer Systems are implemented within GxP requirements.

The incumbent will be responsible for maintaining system inventory of GxP Systems used for the production and support of the sterile manufacturing facility. The working atmosphere will involve a multitude of exciting projects and cross-functional tasks with GxP, QA Compliance, and senior management teams.

Responsibilities:

  • Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, IQ/OQ/PQ etc.

  • Develop department SOPs and provide SOP review for new systems

  • Perform scheduled reviews of existing GxP systems and delineate remediation plans for non-conformance's

  • Maintain GxP Systems records and updates


Qualifications:

  • BS in a related field

  • 2 years experience with computer systems projects/implementations

  • Familiarity with project management practices

  • Familiarity with SDLC, GAMP5 for software implementation, (exp. With Argus a Plus)

  • Ability to work in a project oriented environment

  • Proven ability to work independently

Compensation:

  • $90,000 - 110,00 + excellent bonus + excellent benefits

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