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.
• Bachelor's degree preferred, preferably in Science or Engineering.

Last updated : 2024-05-12