Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of controlWrite protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packagesCoordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidanceMonitor and support the execution of the protocols through training, facilitating and problem solving activitiesProvide guidance and assistance on validation formats, requirements and procedures as a team member on various validation projectsSupport validation training for team members and provide resource information as a technical expertReview completed validation packages for compliance with validation requirementsManage the validation status of the facility and ensure change control by maintaining the facility Master Plan as a current document, and tracking all validation efforts via schedules & status logsMaintain the Site Reference FileEstablish and manage the Validation Maintenance schedulePrepare or assist in the preparation of Validation Maintenance packagesManage the cleaning validation program and update the Cleaning Validation Risk Assessment document, adding new products and equipment as requiredContribute / participate in facility Quality review meetingsParticipate as the Validation SME during Regulatory and Corporate compliance inspectionsSupport the Baxter Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created Required SkillsMust-haves:3+ years of experience in validation of pharma equipmentRegulation & standards (FDA / Health Canada) knowledge Preferred SkillsTools / software / methodology / certification: LIMS, Trackwise, MinitabSoft skills: Multitasker with a can-do or make it happen attitude; Autonomous and has to be able to speak up and raise issues if observed. Be confident.Seniority level: 3+ years of experience
Job Title
Validation Specialist