Full job description*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
Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy.