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QA Reviewer
1 month ago
QA Reviewer - Eurofins BioPharma Product Testing Toronto, Inc.49_744000077273735Obowiązki Eurofins BioPharma Product Testing Toronto, Inc. is seeking a detail-oriented and analytical QA Reviewer to join our team in Toronto, Canada. In this critical role, you will be responsible for ensuring compliance with applicable regulations and maintaining the highest quality standards in our biopharmaceutical testing processes.Review of all analytical data/documents related with R&D and QC testing, e.g.: method validation, method verification, method transfer, finished products, bulk, raw material and stability study products as per GMP requirements.Prepare and review protocol, report and test method for method validation, method verification, method transfer study.Review all raw data and chromatograms using different software (e.g. Empower, Chromeleon, Mass Hunter, Analyst software etc.) and then release report/COA on e-LIMS.Train junior analysts in method validation, method verification and method transfer study including related software usage (Empower, ETQ, Chromeleon, other software associated with LC-MS/MS. GC-MS/MS, ICP-MS/OES).To ensure data integrity is maintained in all the process.Participate in and/or lead out of specifications investigations OOS.Initiate CCR and complete Corrective and Preventive Actions (CAPA’s).Participate in Internal, Customer and Regulatory Audits.Assist laboratory personnel with documentation issues and provides coaching and guidance to R&D team.Perform analysis using different instruments (e.g. HPLC, GC, LCMSMS, GCMSMS, UV-Vis, FTIR) and wet Chemistry techniques.Provide technical support to clients in relation to R&D, Validation and Technology Transfer.Troubleshoot technical issues/ difficulties with methods.Archive all GMP documents related with raw data, test method, protocol & report.May be essential to perform work in weekend, after hours and rotating shift work (as required).Follows up with analysts/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards.Audits calibration related documents and other R&D /QC documents;All other jobs assigned by Department Head of R&D.Review and determine the status of quality documents, including raw laboratory data, validation studies, logbooks, and calibration reportsProvide support in maintaining the Quality System, including drafting and updating quality proceduresAssist with internal and external audits to ensure compliance with GMP and ISO 17025 standardsReview and verify the accuracy of reports and accompanying raw data according to study protocols, methods, and relevant SOPsInteract with department staff to gather information for report writing and auditing purposesLog and review complaints, compiling required ISO 17025 and GMP documents for evaluationManage the internal auditing program and ongoing tracking of GMP and ISO 17025 documentsSupport the training of new staff and review training recordsAssist in maintaining ISO 17025 and GMP accreditationCollaborate with cross-functional teams to ensure consistent quality standards across the organizationWymagania Bachelor's degree or diploma in a science-related disciplineOver 3 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical Company.Ability to work with electronic systems and other lab equipment to be able to perform audit trail of testing records.Knowledge of GC, HPLC, UV, IR, LC-MS/MS. GC-MS/MS, ICP-MS/OES and other analytical instrument.Sound knowledge of Health Canada and FDA regulations.Comprehensive knowledge of ISO 17025 and GMP requirementsGMP experience in the biopharmaceutical industry preferredStrong understanding of quality assurance processes and regulatory compliance in the pharmaceutical industryExcellent written and verbal communication skillsExceptional organizational abilities with a high level of accuracy and attention to detailProficiency in MS Office suite, particularly Excel, Word, and OutlookExperience in quality document review and auditingFamiliarity with corrective and preventive action (CAPA) processesAbility to multitask and remain calm under pressureStrong analytical skills with the ability to interpret and summarize complex dataCollaborative mindset with the ability to work independently and as part of a teamCustomer-focused approach with a commitment to meeting quality standardsWillingness to learn and adapt to new processes and technologiesWORKING CONDITIONS: This position will be working in a laboratory environment where standing is required for greater than 50% of the time. Light lifting requirements of no more than 30 lbs. Hazardous materials are handled using established safety procedures and appropriate PPE. Shift work and overtime may be required, as well as working periodic weekends and/or evenings.Oferujemy At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.caWe thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.This posting is supported by AI technology to assist in screening candidates and resumes.NO AGENCIES, CALLS OR EMAILS PLEASE Źródło: Eurofins/Praca Aplikuj
