Software Validation Specialist - Binaryitech : Job Details

Software Validation Specialist

Binaryitech

Job Location : all cities,NJ, USA

Posted on : 2025-07-25T00:59:42Z

Job Description :

The Software Validation Specialist will collaborate closely with the Clinical Quality Assurance Lead for Systems Audits, focusing on audit and quality.

Responsibilities:

  • Participate in computer system audits to review SDLC and data integrity controls.
  • Review CAPA and verify CAPAs of system audits.
  • Act as a QA approver for internal validation efforts.
  • Serve as a liaison to the business, providing guidance and consultancy on software validation.
  • Support health authority audits/inspections for inspection readiness.

    • Minimum Requirements:

  • Bachelor's degree in associated functional disciplines including IT, Data Sciences, and others.
  • Minimum 4-6 years of experience in the Pharmaceutical industry or similar.
  • Familiarity with software development, encompassing both Agile and Waterfall methodologies.
  • Knowledge of coding matrix and complexity measurements/determination.
  • Familiarity with regulations governing software development and validation.

    • Preferred Qualifications:

  • Knowledge of Statistical Programming, Google Cloud Platform/GMP, and auditing experience.

    • Must possess professional communication skills, strong independent time management skills, and the ability to manage multiple projects concurrently.

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