Job Title: Principal QA Specialist Global BiopharmaceuticalPlease ensure you read the below overview and requirements for this employment opportunity completely. Contract: 12 months Location: Slough (onsite) potential for hybrid after training complete Salary: 31.99 PAYE, 40.47 Umbrella per hour (Inside IR35) Hours: 37.5 hours per weekReports to position QA Manager (QA Technical Support)Job Title Associate Principal QA Specialist, QA Technical OperationsPrimary Location SloughRole Purpose & Scope (why does this job exist and what scope does it cover?)Support Operations to ensure Compliance to GMPManage and support GMP issues through QMS processes, site governance and senior QA leadership.Act as a GMP SME by implementing, managing and enforcing quality processes on site.Supporting Senior QA leadership to drive continuous improvement and fitness for purpose. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and our clients Customer expectationsKey Responsibilities To provide shoulder to shoulder review, approval and support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations, OOS.Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAsTo actively identify, suggest and participate in continuous improvement activitiesMentor and coach business partners in cGMP practices to maintain and develop a cGMP environment and quality cultureMaintain and promote a state of audit readinessActively suggest, initiate, participate and contribute to PQS process improvement initiatives and projectsProvide QA SME support at departmental Local Quality Councils and project meetingsProvide QA SME Support for manufacturing during out of hoursPerforms other duties as assigned.Key Metrics KPI Targets (in addition to abiding relevant quality systems standards (ISO 9001, ISO 13485) & where relevant complying to applicable pharmaceutical GMP standards (US and European) / 21CFR820 as well as abiding & role modelling for all Health, Safety and Environmental rules and guidelines)Deviation assessment completed within 2 daysZero overdue quality recordsKey Stakeholders Please specify the stakeholder positions the role will interact withManufacturing Operations (Cell Banking, Fermentation, Purification and Manufacturing Support)Warehouse and Supply ChainRequired Skills & Competencies (e.g. technical, interpersonal, problem solving)Excellent decision-making and problem solving skills.Strong Quality mindsetStrong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues.Strong Continuous Improvement mindsetExcellent communication skills (verbal and written).Ability to meet strict deadlines.Excellent organizational and planning skills.Qualifications (Min. requirements to perform assigned tasks)Education/DegreeField of Study - ScientificLanguage(s)Required English2 - Business FluentWork Experience Area Quality (QA or QC)Level Advanced - 5-10 years
Job Title
Associate Principal QA Specialist