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Job ID : 27711

Location : New Jersey, NJ

Company Name : LS Solutions Inc.

Job Type : Full-Time, Contract, Training

Industry : Biotech/Pharmaceutical

Salary : $57,000 - $60,000  per year

No. of Positions : I Have Ongoing Need To Fill This Role


Required Skills : Computer Systems Validation

Benefits : Medical Insurance


Job Description :

Key Responsibilities

  • Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry.
  • Required Bachelor's degree in pharmaceutical Science OR related field of study.
  • Schedule and plan equipment and process qualification workload to meet approved schedules.
  • Handle multiple projects and be able to work independently as required.
  • Develop GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional Design Specifications, Configuration Specifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptance testing, Traceability matrix, System and Validation reports, SOPs, Change Control Documentation, and Risk assessment/FMEA reports as required.
  • Establish critical parameters, plan, design, and implement validation projects and protocols.
  • Ability to author, execute, and thoroughly review complex protocols and documentation.
  • Coordinate validation activities with other departments.
  • Stay current with industry qualification trends through FDA, ISPE, EU and bench marked companies.
  • Consult, coordinate, cross-function with various personnel within the company and externally.
  • Have the ability to problem solve with minimal oversight, including conducting research to aid in the resolution of issues that arise.
  • Train and mentor other Validation personnel as necessary.
  • Determine and acquire necessary supplies and equipment for validation activities (Planning).
  • Administer the site Change Control/Management Program.
  • Make decisions representing QA in multi-functional teams.
  • Plan and assist with the Global serialization project (as necessary).
  • Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP is desirable

Key Requirements  

  • Minimum Bachelor’s Degree
  • Significant experience in pharmaceutical/biotechnology or related industry, as well as Quality Assurance
  • Cleaning Validation/Process Validation experience preferred
  • Experience with commissioning/qualification of equipment, change management or change control experience
  • Independent and flexible worker that can readily adapt to changing priorities in a fast-paced environment
  • Demonstrated attention to detail and excellent oral and written communication skills

 

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