"Alerted.org

Job Description

Own and maintain the site’s Validation Master Plan (VMP), ensuring compliance with regulatory and internal standards.

Execute software validation activities in alignment with the VMP or as required by CAPAs, audit findings, or regulatory changes.

Perform periodic reviews and retro-validation of existing software systems to maintain compliance.

Conduct Part 11 assessments for new and retro-validated software to ensure adherence to electronic records and signature requirements.

Serve as Subject Matter Expert (SME) for software validation during internal and external audits.

Collaborate with business and IT teams to plan and execute validation activities, including:

Authoring validation plans, protocols, and reports.

Managing and closing IQ, OQ, and PQ validation phases.

Identifying and resolving validation deviations.

Perform risk assessments and classifications for software systems, determining validation scope and testing strategies.

Investigate systems and document findings, ensuring all processes follow established procedures.

Develop and write validation documentation, including protocols and reports, in compliance with documented processes.

Lead validation efforts for software systems, ensuring logical risk-based testing approaches:

Analyze system functions and associated risks.

Define functional separation and appropriate test strategies.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Ownership of the validation master plan for the site.

• Follow-up and executing software validation activities in accordance with VMP or as a result of CAPAs, internal or external audit findings.

• Perform periodic reviews and retro validations on software’s.

• Performing Part 11 assessments for new and retro validated software.

• Participation in internal and external audits as subject matter expert for software validation.

• Working with business and IT representatives to execute on validation activities, identifying and resolving validation deviations, authoring of validation plans, reports, and follow up on closure of IQ, OQ and PQ validation.