Main Responsibilities:
·Perform QA oversight of the Validation review and qualification activities to ensure GMP equipment, facility and/or systems are continuously maintained in a validated/qualified state
·Schedule own tasks to be performed as well as tasks for Level 1 as determined by the Validation Manager
·Perform change control assessments for GMP equipment, facility and/or systems and associated validation activities to ensure compliance with regulatory requirements
·Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment
·Develop validation protocols from Validation plans (if applicable)
·Provide strong technical expertise when reviewing and approving SOPs, protocols, reports, change controls, deviations and other records
·Perform assigned Quality Systems activities including Document Management System (DMS), Laboratory Information Management System (LIMS), Validation and Qualification Management System (Kneat) and Trackwise system (Change Control, Deviations, CAPA, etc.)
·Perform other duties as assigned
Qualifications and Experience:
·Relevant working/residency permit or Swiss/EU-Citizenship required
·Bachelor’s degree in Science or Technical
·3+ years of experience in QA Validation of equipment, facility and/or systems within Pharma
·Experience with oversight of aseptic processing and the associated international aseptic processing regulations
·Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic
·Ability to interface and communicate directly with clients is required
·Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects