Analyst, IT Validation
Company: Katalyst Healthcares & Life Sciences
Location: South Plainfield
Posted on: May 28, 2023
- Validation Services and Technical Writing
- Creation, review, approval, and processing of Computer System
Lifecycle deliverables including:
- User Requirements, Specifications, Test Plans, and IQ, OQ or PQ
- Implementation of the most appropriate validation methodology
for the Business effort.
- Fostering of effective relationships with IT customers to
better understand processes and requirements and attaining the most
beneficial computer system solutions that meet all relevant
- Active engagement with ISQA to ensure compliance on IT projects
and enhancement efforts.
- BS/Equivalent Training/Certification and minimum of 2 years of
relevant experience in computer systems validation, systems
development life cycle methodologies and change management.
Necessary Knowledge, Skills, and Abilities
- Expertise in computer system validation, Systems Development
Life Cycle (SDLC) methodologies.
- Knowledge of computer system regulations, standards, and best
- Strong versatility of written and verbal communication skills,
including documentation of requirements, technical solutions, and
primary validation documentation
- Demonstrate strong technical writing skills and ability to
teach others in the application of technical writing
- Technical knowledge of the following computer systems and
software (at a minimum):
- Microsoft software packages such as Outlook, Word, Excel,
PowerPoint, Explorer, and MS Project
- Veeva Vault
- Document Management Systems /QA Systems.
- Working knowledge of project management principles, and ability
and experience to operate under tight timelines, within budget and
to specified quality and compliance goals.
- Solid relationship and conflict management skills and ability
to navigate complex, fastmoving, and constrained business
environments in a self-directed manner.
- Strong work ethic, learning and change agility, operates
comfortably and effectively in an ambiguous and fast-paced
Keywords: Katalyst Healthcares & Life Sciences, New York , Analyst, IT Validation, Professions , South Plainfield, New York
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