Quality CSV Consultant

Location: Rahway, NJ

Job Description

Our client, a leader in the pharmaceutical industry, is looking for a Quality CSV Consultant to join their dynamic team.

Job Overview 
The candidate is responsible for QA oversight of planning, execution and summarization of CSV activities. The CSV activities requiring QA oversight
will deal with a broad array of systems and areas. The general requirement will be in the review of System Development Life Cycle (SDLC) documentation for standalone COTS laboratory instruments, SDLC and change control documentation for automation systems and automated facilities and equipment and general QA expertise to support area operations. Specifically, SDLC deliverables to be dealt with are:
  • Quality Assurance Plans, Configuration Specifications, Requirement Specifications, supporting verification and/or testing against requirements (all types of testing documentation), Trace Matrices, QASR and other summary documentation as well as change control records, retirement plans, standard operating procedures and system documentation indexes.
  • Ensuring that all of the Clients personnel and contractors follow the required procedures and regulations to ensure that all of the various items, systems and personnel are in compliance. Various enterprise tools, such as an electronic document management system, digital testing systems and change control tickets, will be utilized.
  • The candidate is expected to provide leadership and direction to system project team members in a wide variety of QA matters and specific regulatory matters dealing with data governance.
  • Participates, assists and provides QA oversight in the development of SDLC deliverables supporting all of the GMP operations at the site to ensure applicability and compliance with internal and external policy and regulations.
  • Reviews various GMP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.
  • Identifies and resolves issues interfering with execution of deliverables. Implements practices designed to eliminate or minimize reoccurrences.
  • Enforces Good Documentation Practices and ensures that SDLC deliverables are properly catalogued and available for internal and external regulatory inspection.
  • Supports MRLIT enterprise application QA in addition to local systems as required and has experience in digital testing and testing methods.
  • Ensures that when documents are fully reviewed that approval by the QA representative does not require additional review or additional editing cycles.
  • Bachelor's degree in Computer Science, Engineering, Information Science, Mathematics, Life Science.
  • Previous experience directly in a regulatory quality role as part of the independent Quality group supporting GMP systems and operations (not IT compliance or IT validation/testing execution or management)
  • Demonstrated mastery of computer systems validation and quality management systems principles in a GMP environment.
  • Previous experience with pharmaceutical/biotech research and development including Lab/shop floor/operations setting (preferably preclinical environment and in QA).
  • An experienced person with 5-8 years (minimum) of applicable Quality experience
  • Understanding of laboratory instrument landscape and corresponding technologies/computing.
  • Understanding of GMP enterprise and sitewide systems (such as LIMS, CDS and EMS) and corresponding technologies/computing.
  • Understanding of the process and operations Automation and controls landscape and corresponding technologies/computing
  • Exceptional understanding of data governance and ALCOA principles.
  • Demonstrated ability to negotiate and mediate quality assurance issues.
  • Excellent written and oral communications and presentation skills.
  • Demonstrated ability to analyze problems and identify and justify corrective and preventive actions.
  • The ability to work independently with minimal supervision and/or oversight.

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