Quality Assurance Specialist

4 days ago

Welwyn, United Kingdom SCIOM Limited Full time

Direct message the job poster from SCIOM LimitedSciom Limited is dedicated to maintaining the highest standards of quality and compliance in the pharmaceutical industry. We are seeking a detail-oriented and experienced Quality Assurance (QA) Specialist to join our dynamic team. If you have a passion for quality and a keen eye for detail, we would love to hear from you.Role OverviewThe QA Specialist will oversee the Quality Management System (QMS), QA activities, batch testing review, and release processes. This role ensures compliance with all regulatory standards and maintains the highest levels of quality throughout the production lifecycle.Key ResponsibilitiesQMS: Initiate and review change controls, deviations, complaints, OOS/OOT, and incidents in accordance with GMP compliance.Quality Management Reviews: Ensure QMRs, KPIs, and trend analyses are performed according to internal procedures.QMS Dashboard: Review and monitor QMS dashboard activities.Pre-QP Review: Prepare and review the Importation to Batch Release checklist to ensure all documentation, testing requirements, and regulatory conditions are fully met prior to final product release.Outsourced Activities: Prepare, review, and approve quality technical agreements with outsourced service providers.GMP Operations: Ensure all GMP operations are conducted within the scope of Sciom licenses and applicable guidelines.Qualification Documents: Review qualification documents of outsourced services to ensure GMP compliance.Monitoring and Reporting: Monitor and report on the effectiveness of the QMS within the organization and at outsourced service providers.Standard Operating Procedures (SOPs): Prepare and review departmental SOPs, work instructions, and forms.CAPA Verification: Review closed QMS actions and verify the effectiveness of CAPA.Audits: Assist the Qualified Auditor in performing audits at service provider facilities.Performance Monitoring: Monitor performance and help identify improvements and effectiveness of quality activities.Software Validation: Perform and review software validation activities and related documentation.Data Review and Approval: Review and approve QC testing data, instrument qualification data, and method validation/method transfer data.Trend Analysis: Perform trend analysis of QC analytical results and investigate any OOT/OOS analytical results according to relevant SOPs.Training: Provide training to personnel on SOPs, work instructions, forms, and GMP compliance.QualificationsA Bachelor's or Master’s degree in a relevant field such as Life Sciences, Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline.Minimum 2 years of experience in quality assurance within the pharmaceutical industry.Strong knowledge of GMP, regulatory standards, and quality management systems.Experience with QMS, CAPA, audits, QC data review, and software validation is highly desirable.Strong knowledge of HMR 2012, EU GMP, the MHRA Orange Guide, and other relevant regulatory and quality guidance requirements (e.g., ICH guidelines and GDP).Excellent attention to detail and problem-solving skills.Strong communication and training abilities. #J-18808-Ljbffr

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