Job Description:
The Software Validation Specialist will collaborate closely with the Clinical Quality Assurance Lead for Systems Audits, focusing on audit and quality
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 but not required: 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.