Quality Assurance Manager

Job Description

Quality Assurance ManagerAn exciting opportunity for an experienced Quality Manager to lead a dynamic and vibrant team at a great company. On offer are a competitive salary and excellent benefits package.Job PurposeThe Manager, Quality Assurance, is responsible for providing professional expertise and leadership in the Quality function. The Manager is responsible, along with the Senior Manager, Quality, for ensuring compliant GMP operations are continuously maintainedacross the site. Responsibilities include direct supervision of the QA team charged with the review and management of investigations, including root cause, product impact and CAPA, GMP document review, batch manufacturing record review, and executing the internaland external audit program. The incumbent will also play a vital role during client and regulatory agency audits. The Manager, Quality Assurance will interact with customers through routine production activities as well as via the support of client audits.Responsibilities

• Provide leadership and management within the QA department through a structured process of objective setting, performance appraisal, and individual development. By improving individual performance and group collaboration, the manager will be responsiblefor improving the overall department productivity and efficiency
• Assist the senior manager, quality with the development, implementation, optimization and strict adherence to a quality assurance program
• Oversee the sites quality assurance program. This includes overseeing and assisting with the sites training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports,analytical reports, and manufacturing records
• Develop and/or review and/or approve standards, policies, and procedures for all functions on site and departments involved with or related to the production and testing of all materials, as assigned
• Provide quality oversight and review the validation program including process validation, cleaning validation, computer software validation, and instrument qualification
• Collect, monitor and report quality key performance indicators identifying and leading opportunity for improvements to achieve and maintain high quality, productivity and efficiency of the QA department
• Provide support during regulatory inspections and customer audits. Assist in performing inspection readiness activities and supplier audits
• Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function
• Manage the Quality Events Management System for deviations, failure investigations, out of specification/out of trend investigations, calibration out of tolerance events, CAPAs and CAPA effectiveness monitoring plus change control. Ensure that all QualityEvents are completed in the time required by company procedure and that all investigations are completed in a thorough manner to appropriately identify root cause and corrective/preventative actions. Authorize critical deviations and provide guidance and troubleshootingduring investigation
• Identify, lead and support QA team continuous improvements initiatives
• Report serious or repeated failures or unreliability in quality of products to Senior Manager, Quality
• Effectively communicate with internal and external customers making sure that the company values and business goals are consistently achieved
• Maintain qualification, knowledge and understanding of regulatory requirements for GMP operations

Requirements

• Hold a Science related qualification, at degree level or equivalent
• Wide knowledge of regulatory requirements and GMP
• Knowledge and experience of EU GMP and Quality Assurance
• Experience in an aseptic manufacturing environment
• Strong proven leadership, management and team working skills, including driving people and performance processes, setting objectives and KPIs
• Experience working in cross department groups and fostering collaborative working
• Experience in the use of continuous improvement systems
• Strong problem-solving skills
• Demonstrated proactive and organised approach, and proven ability to prioritise and manage multiple tasks
• Customer related experience and client facing skills, particularly in audit capacity
• Ability to communicate and work with personnel of all levels, internally and externally
• Proven flexibility in adjusting to a rapidly evolving workload and remaining calm under pressure
• Experience gained within an Analytical Chemistry lab environment would be advantageous
• Excellent level of organisational skills
• Excellent time management skills
• Excellent levels of documentation; legible writing; clear structure
• Must be thorough / detail orientated, can multitask and possess strong organisational and communication skills. Work well with others and be a team player

Next Steps:Apply online in the first instance, or contact Liam Baxter at Tel: , or email your CV toEqual Opportunities:FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process