We are looking for Validation Specialist with great aptitude, leadership and character to learn and complete important projects with our pharmaceutical clients in Puerto Rico. This is a learning opportunity full of new experiences and challenges with high innovative technologies.
Responsibilities may vary from:
1.Plan, develop, and implement documentation, procedures, and trainings necessary for the engineering team.
2.Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports.
3.Manufacturing processes transference validations and related activities.
4.Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
5.Troubleshooting processes that do not perform as intended during validation runs.
6.Recommend process/quality improvements as part of validation runs.
7.Work with new and existing equipment, processes, utilities, facilities and cleaning validations.
8.Evaluate, investigate and document non-conformance incidents and/or protocol deviations.
9.Prepare information for Quality Management Reviews and Operational Reviews such as: trending charts, Pareto analysis, etc.
10. Other related duties necessary in the job site.