Quality Assurance Associate
hace 3 días
Slough
• Job title: Associate Principal QA Specialist, • Location: Slough, • Contract Length: 12 months, • Working Hours: 37.5 hours/week, • Pay Rate: up to £32.76 p/h DOE About the Role • Provide QA review and oversight for various studies and activities., • Support a culture of quality and continuous improvement within QC and Development Services., • Support Operations to ensure ongoing compliance with GMP., • Manage and support GMP issues through QMS processes, site governance and senior QA leadership., • Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site., • Support senior QA leadership in driving continuous improvement and ensuring processes are ‘fit for purpose’., • Ensure compliance with GMP requirements within Development Services., • Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements. Key Responsibilities • Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records., • Review QA activities for MSAT studies, pilot studies, and Development Services., • Review QC activities including method validation, reference standards and stability studies., • Manage and escalate critical compliance issues through the QMS., • Conduct audit trail reviews., • Perform area walkthroughs to identify and resolve non-compliance., • Audit raw data, protocols and validation reports for GMP compliance., • Maintain and promote audit readiness., • Ensure protocols and validation reports are approved according to project schedules., • Lead process audits and support GMP audit activities., • Identify and participate in continuous improvement initiatives., • Support quality governance via Local Quality Councils and project meetings., • Provide QA SME support for Operations, QC, MSAT and Development Services., • Mentor and coach business partners in GMP practices., • Advise scientists on documentation and follow-up expectations., • Provide out-of-hours QA support where required., • Act as a GMP SME enforcing site quality processes, • Perform additional duties as assigned. Skills/education • Education/Degree: Field of Study Scientific, • Work Experience: Quality (QA or QC) Level- Advanced - 5-10 years, • Top three must have experience: QA Manufacturing experience, TrackWise records experience (Deviations, Change controls, CAPA’s, investigations) OOS investigations, • Nice to have experience: Audit experience