Job description

Validation Specialist

Location: The candidate must be able to work onsite 50% of the time at New Brunswick, NJ so local candidates only please.
Duration: 6+ Months

Job Description:

Must Haves:

• 2+ years of experience in managing the projects as CSV specialist
• 2+ years of experience in testing , (script reviewing from a QA perspective in particular )
• 2+ years of experience in authoring , reviewing various validation documentation such as (Val plan , Risk assessments etc.)
• Good communication and writing skills
• Knowledge of GAMP and 21 CFR Part 11

6+ years’ experience
Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
Follow SOPs and industry best practices
Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
Review validation deliverables for projects which are contracted to third party suppliers
Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
Assist in planning, implementing, and documenting user acceptance testing

• Review computerized systems validation documents such as:
• Requirements Specification
• Design Specification
• CSV Risk Assessment
• Test Plans
• Test Summary Reports
• Data Migration Plan
• Pre/Post Executed Test Scripts
• Traceability Matrix
• Release to Production Statements

Direct and review testing
Provide guidance on quality issues that affect the integrity of the data or the system
Obtain and respond to QA review
Participate in establishing standard quality and validation practices
Independently assess compliance practices and recommend corrective actions
Approve validated computer system related change requests
Monitor regulatory and inspection trends and advise the business on suitable action
Ability to create documents to an existing document standard.
Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
Once trained, have the ability to work independently on CSV projects with minimal oversight.
Ability to perform in a highly matrixed organization structure

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Contract, Temporary

Pay: Up to $74.32 per hour

Benefits:

• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• testing (script reviewing from a QA perspective): 2 years (Required)
• authoring , reviewing various validation documentation: 2 years (Required)
• GAMP and 21 CFR Part 11: 2 years (Required)
• managing the projects as CSV specialist: 2 years (Required)

Work Location: Hybrid remote in New Brunswick, NJ 08901

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