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Associate Principal QA Specialist
- Slough, England, United Kingdom
- Slough, England, United Kingdom
À propos
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 experienceGuidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy
Compétences linguistiques
- English
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