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Job Id : 6503

Jobtitle : Validation Analyst

Location : Princeton, NJ

Company Name : APLOMB Technologies

Industry : Information Technology

Salary : $10,000 - $80,000  YEAR

Job type : Fulltime

Posted on: 2019-11-02


Required Skills : Systems Validation, Subject Matter Expert, GxP Systems, Audit

Benefits : No benefits are available


Job Responsibilities:

  • Validation of GxP and non-GxP systems to provide confidentiality, integrity and availability of data, regulatory compliance and reliability of systems to support business operations.
  • Provide technical leadership and accountability for GxP Clinical systems validation and ensure compliance with internal and external policies and regulations.
  • Ensure Business, IT and Quality teams are fundamentally aware and proactively implement current GCP system validation practices with focus on impact to patient safety, product quality and data integrity.
  • Subject Matter Expert of validation activities including-Conduct, review and approve risk assessments in compliance with company QualityRisk Management policy
  • Classify of GxP and non-GxP clinical systems, automated laboratory equipment and associated business system interfaces.
  • Perform Data Integrity assessment
  • Develop, review and execute Validation deliverables throughout the system lifecycle
  • Audit vendors for compliance with policies to leverage vendor documents during validation effort
  • Develop and Execute Operational, and Performance Qualification (OQ and PQ) protocols, and prepare a Validation Summary Report
  • Ensure compliance with regulatory requirements (US FDA and Annex 11) and internal procedures by monitoring, reviewing and assessing the system implementation activities
  • Contribute effectively in change control, deviations, periodic reviews, VMP's and SOP updates.
  • Support regulatory inspections and internal and supplier/third party audits, and implement corrective actions as needed. Provide Validation related responses to auditors/inspectors.

 

Qualification:

  • This position requires, at a minimum, a bachelor s degree in Biotechnology, Pharmaceutical Sciences, Regulatory Affairs, Biomedical Engineering or a combination of education and experience equating to the U.S. equivalent of a Bachelor s degree in one of the aforementioned subjects

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