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