GxP Validation Analyst

Highland Heights, OH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

Documenting and validating instrument software per EMA guidelines.
Migrating instrument software management into PPD IT SOP frameworks.
Capturing requirements configurations and compliance documentation to ensure end-to-end traceability and regulatory compliance.

Responsibilities:

Gather and document requirements (URS software configuration).
Develop and execute validation test cases (IQ OQ PQ as applicable).
Prepare requirements specifications infrastructure diagrams and data flow diagrams.
Conduct risk assessments and ensure traceability (requirements risks tests results).
Support SOP migration and alignment with PPD IT practices.
Communicate effectively with lab teams IT QA and external vendors.

Requirements:

Strong technical writing and documentation skills.
Proven experience in software validation of lab instruments / other GxP systems.
Good understanding of EMA guidelines Annex 11 and GAMP 4.
Ability to design and interpret infrastructure and data flow diagrams.
Detail-oriented with strong stakeholder engagement and communication skills.
6 9 years of relevant validation experience in pharma biotech or CRO environments.
Familiarity with CSA (Computer Software Assurance) principles preferred.

Job Description: Documenting and validating instrument software per EMA guidelines. Migrating instrument software management into PPD IT SOP frameworks. Capturing requirements configurations and compliance documentation to ensure end-to-end traceability and regulatory compliance. Responsibilities...