Responsibilities
- Performs validation document generation, program management, and protocol execution activities.
- Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
- Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
- Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
- Perform qualification activities according to site objectives and timelines.
- Edit department SOPs and generate basic revisions as required.
- Execute CAPA plans, risk assessments, investigations, and root cause analysis.
- Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
Requirements
- Working understanding of validation concepts and requirements.
- Intermediate written and verbal communication skills.
- Knowledge of cGMP.
- Critical reasoning and decision-making skills.
- Knowledge of validation industry and regulatory requirements.
- Ability to work independently and participate in a team.
- Work and time management skills.
- Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
- CAPA, GXP System Validation / CFR Part .
- Bachelor's degree preferred, preferably in Science or Engineering.
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