Computer Systems Validation

25 Nov 2024

Vacancy expired!

Job Title: Computer Systems Validation

Location: Allandale, NJ

Job Description:

Position SummaryThe purpose of Computer Systems Validation Specialist is to carry out Validation and Compliance activities on the Computer Systems used for GMP activities. CSVS ensures that all computer-based Lab and Manufacturing systems will carry out the functionalities and produce information or data that meet predefined requirements. CSVS is required to create and execute documents that will ensure with evidence that the Business and Regulatory requirements are adequately implemented. CSVS is required to carry out the 21 CFR Part 11 assessment and Risk assessment on the Computer Systems. CSVS does the research and advise the Systems owning departments for improving the systems for compliance. CSVS will be responsible for maintain the Computer Systems in Validated State.

Essential Functions and Responsibilities· Carry out 21 CFR Part 11 Assessment for the Computerized Systems.· Develop Validation deliverables such as Validation Plan, User Requirements Specifications, Design Specifications, Functional Specification, Qualification Protocols, Traceability Matrix and validation Summary Report.· Receive comments and feedback from the team and update and finalize Validation deliverables.· Upload the Validation deliverables and Obtain approval for execution.· Configure the Computer System as per the specifications in collaboration with IT and Vendor.· Configure the system onto the network, LDAP, System Login, Users and Roles in collaboration with Business Owner and IT.· Dry run the Qualification scripts on the Computer Systems.· Execute Qualification protocols on the Computer Systems following Good Documentation Practices.· Initiate and resolve deviation and discrepancies in the Qualification protocol execution.· Develop Standard Operating Procedures and Work Instruction as needed.· Develop and execute Backup and Recovery; and Disaster Recovery policies and procedures as needed.· Monitor the Computer Systems for any compliance issues and help to maintain the Computer Systems in the Validated state.

Competencies· Microsoft Office suite· Basic Networking knowledge· Basic Database knowledge· QT9 working knowledge· Problem Solving· Analytical skills

Supervisory Responsibility· This job has no supervisory responsibilities.

Qualifications· Education: BS Degree in Science or Technology· Specialized knowledge: 21 CFR Part 11 regulations, GAMP Practices, GLP Practices, Google Cloud Platform Practices· Skills: MS Office, Networking, DBMS· Years of experience 3 to 5 year

  • ID: #23462229
  • State: New Jersey Allendale 07401 Allendale USA
  • City: Allendale
  • Salary: Depends on Experience
  • Job type: Permanent
  • Showed: 2021-11-25
  • Deadline: 2022-01-14
  • Category: Et cetera