Validation Specialist

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job title: Validation Specialist

Location: Princeton, NJ

Duration: 6+ Months

Job Description:

3-4 years’ experience in computer system validation regarding GXP environment

Strong skills in testing tool such as HP ALM or JIRA

Experience with ServiceNow is a plus

Authoring and reviewing validation deliverables a plus

Strong communication Skills. They will work with NSP, Tampa as well as the offshore team.

Responsibilities

• 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

• 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