- The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems.
- Qualification of laboratory instruments, setup of computers and instruments, troubleshooting of system related issues, and technical writing and execution.
- Executes validation projects, system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.
- Working understanding of validation concepts and requirements.
- Intermediate written and verbal communication skills.
- Knowledge of cGMP.
- Critical reasoning and decision making skills.
- Knowledge of validation industry and regulatory requirements.
- Ability to work independently and participate in a team.
- Work and time management skills.
- Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
- Performs validation document generation, program management, and protocol execution activities.
- Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
- Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
- Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
- Protocol execution and project activities.
- Execute qualification activities with oversight.
- Participate in department and site project teams.
- Perform qualification activities according to site objectives and timelines.
- Edit department SOPs and generate basic revisions as required.
- Execute CAPA plans, risk assessments, investigations, and root cause analysis.
- Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
- Defend validation protocols in internal and external audits as a subject matter expert with limited supervision.
- Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
- Performs general administrative and organizational activities.
- Management of time and work deliverables, regular interface and reporting to management.
- Complete regulatory, site, and department training requirements on a timely basis.
- Perform other tasks as assigned.
- Bachelor's degree preferred, preferably in Science or Engineering.
- 8 years relevant work experience required.
- An equivalent combination of education, experience and training may substitute.
- The incumbent may be required to gown and operate in classified manufacturing environments.
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Validation Specialist - Warren, United States - Rangam
Description
Pay Scale: $60.00 -$63.00 per Hourly
Job Description:
100% Onsite in Warren, NJ
Lab w/o blood & animal
Duties:
Primary responsibilities include:
Required Competencies:
Knowledge, Skills, and Abilities:
Duties and Responsibilities:
Education and Experience:
Working Conditions
