Validation Specialist

Job Description

Candidate must have strong 5 years plus GXP system validation with Cloud.

Key Areas Of Job Accountability

The Validation Specialist will support computer system/computerized equipment validation activities, ensuring compliance

with company policies and procedures. This role encompasses local and global enterprise systems as well as SaaS

(Software as a Service) solutions. The position reports to the Manager of Validation.

Validation Activities

Requirements gathering, validation planning, design qualification.

Authoring and executing test plans and scripts.

Discrepancy management.

System-Based Risk Assessments

Authoring system description and validation summary reports.

Determine GxP applicability, associated risks, and validation activities.

Lifecycle Support

Development, review, and execution of validation documentation during projects and operational phases.

Operational Phase Support

Perform change impact assessments, determine testing requirements, author and execute related test scripts, and complete change qualification reports.

Periodic Reviews

Conduct periodic reviews of computer systems and user access.

Business Administration

Administer the electronic system (ValGenesis) for validation lifecycle management.

Train end users on ValGenesis.

Manage and update Validation Templates in ValGenesis.

Academic/Technical Qualifications

Bachelor's degree in a Science or Engineering discipline. 5 years of relevant experience in computer system validation.

Specialist/Technical Qualifications/Knowledge: Experience with computer systems supporting R&D functions (Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs, Quality Assurance) is a plus. Experience with ValGenesis is a plus.

Practical experience with quality risk management and risk-based validation approaches. Knowledge of cGMP regulations and guidelines (U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, ICH Q7, Q8, Q9, Q10)