Quality Assurance Specialist
Search is working with our client in the Pharmaceutical sector to recruit a QA specialist for a 1 year contract role based in Slough:Role purpose:Support Operations to ensure Compliance to GMP 路 Manage and support GMP issues through QMS processes, site governance and senior QA leadership. 路 Act as a GMP SME by implementing, managing and enforcing quality processes on site. 路 Supporting Senior QA leadership to drive continuous improvement and 'fitness for purpose'. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and Lonza's 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. 路 Utilise 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 CAPAs 路 To actively identify, suggest and participate in continuous improvement activities 路 Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment and quality culture 路 Maintain and promote a state of audit readiness 路 Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects 路 Provide QA SME support at departmental Local Quality Councils and project meetings 路 Provide QA SME Support for manufacturing during out of hours 路 Performs other duties as assigned.Required Skills:Excellent decision-making and problem solving skills. 路 Strong Quality mindset 路 Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues. 路 Strong Continuous Improvement mindset 路 Excellent communication skills 路 Ability to meet strict deadlines. 路 Excellent organizational and planning skills. Previous experience as QA approver of Deviations, CAPAs, Change Controls, OOSs.
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