Description:
About the CompanyProclinical is seeking Validation Associate to join a global Biopharmaceutical leader renowned for its innovation and commitment to delivering medicines to treat health conditions and improve quality of life. At their Parkville site, they manufacture vaccines including influenza and Q fever vaccine as well as Products of National Significance such as Antivenoms.About the RoleThe Validation Associate is responsible for performing validation activities associated with changes to existing plant, equipment, and processes and revalidation of processes and equipment for the organisation in addition to project validation and routine revalidation activities.Team Size: 10 peopleDuration: Till end of 2025Start Date: ASAPHours: Standard Mon-FriCapacity: Majority on-siteLocation: Parkville
ResponsibilitiesPerform the validation activities for project workPerform validation activities in accordance with the Quality Management System, Site Validation Master Plan, Business Improvement and Validation procedures to meet the requirements of all codes, regulations and policiesPrepare, implement and maintain departmental documentation for validation activities and regulatory submissions (i.e. Validation protocols and reports, Executive Summaries and Validation Master Files)Build and maintain strong collaborative relationships with key stakeholdersActively participate in problem solving and identify opportunities for improvement to optimise validation activitiesTemperature mappingMedia fillsSOP updatesDrafting Protocols and reportsExecuting validation activation, equipment validationHVAC protocol review, temperature mapping
Skills and ExperienceTertiary degree in Science, Pharmaceutical Science or related degreeValidation experience in the pharmaceutical industryCleaning and equipment validation experienceAutoclave validation, process validation and media fill experience (highly desired)Computer Systems Validation experience (highly desirable) Documentation experience in validation, protocols, and reportingGood stakeholder management skills with the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functional teams within the business.Computer literacy and proficient with Microsoft applications
How to ApplyTo apply for this opportunity, please click on the APPLY NOW button.For further information, please contact Pamela Phoumavong at p.phoumavong@proclinical.com
About ProclinicalProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.Proclinical Staffing is an equal opportunity employer.
22 Mar 2025;
from:
uworkin.com