Validation Specialist Job at Katalyst Healthcares & Life Sciences, Portsmouth, NH

c2hPNHpIVVBtR29VejlNUzJrL3YwUW52M2c9PQ==
  • Katalyst Healthcares & Life Sciences
  • Portsmouth, NH

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Responsibilities:

  • CSV, Analytical and Enterprise Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate.
  • This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first-time performance.
  • Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of CSV, analytical and enterprise systems/applications.
  • Review and Approval of Installation

    Qualifications

    /Operational

    Qualifications

    and drafting Performance

    Qualifications

    as required.
  • Assist in generating User Requirements Specification Documentation, Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
  • Prepare Administration and Configuration specification document with support from vendor user manual.
  • Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
  • Performs user and application software administration on Enterprise systems. Works on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems.
  • Create and or Revise SOPs for CSV, Analytical and enterprise systems and applications.
  • Participate on Risk Assessments.
  • Review/Approve Commissioning Qualification Validation Documents.
  • Perform other duties as assigned.

Requirements:

  • Bachelor of Science - Science related discipline or relevant experience in the field.
  • Experience 5-10 Years.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

Similar Jobs

Johns Hopkins Medicine

New Grad RN - MPCU Job at Johns Hopkins Medicine

x JHM prioritizes the health and well-being of every employee. Come be healthy at Hopkins! Diversity and Inclusion are Johns Hopkins Medicine Core Values. We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences...

Tekarch technology

QA Automation Tester Job at Tekarch technology

 ...perfect solution for you!We offer a Training & Placement Program in QA Automation Testing designed to help you successfully transition into the software industryeven with no prior IT experience.Program Highlights:Duration: 3 MonthsHands-on Training in QA Automation... 

Fellers

Remote Bilingual Customer Service Representative Job at Fellers

 ...trusted leader in delivering speed , service , and selection to our customers. This is backed by a national...  ...communication skills Ability to prioritize work and manage time effectively Basic...  ...for extended periods Work at home requirements Quiet and... 

Otsuka America Pharmaceutical Inc.

Medical Science Liaison- CNS (Chicago) Job at Otsuka America Pharmaceutical Inc.

 ...clinical trials to ensure optimal site selection and performance.+ Support other areas of the organization including Safety & Pharmacovigilance for investigation of safety-related issues, Sales Training medical education on an ongoing basis including new hire and POAs,... 

Bald Head Island Transportation, Inc.

Dispatcher -FT Job at Bald Head Island Transportation, Inc.

 ...Dispatcher Regular Full-Time GENERAL STATEMENT OF JOB Under general supervision performs shift work at Bald Head Island Transportation Ticket Office. Efficiently dispatches tram and driver resources to transport customers to their island destination and subsequent...