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)
Bachelor's degree