QA Manager

Summary The QA Manager will lead, manage and develop quality assurance staff within the compounding unit in Thetford ensuring appropriate risk identification and management processes are implemented. You will have direct experience of Aseptic Manufacturing within a pharmaceutical/medical devices/food manufacturing company and at least 3 years’ experience in a leadership position. Essential Duties and Responsibilities Effective management of the QA Team ensuring they are performing against objectives Over see the sites risk management process and updating risk assessments where required To drive Continuous Improvement as a result of risk identification and opportunities to improve Ensures that all product released meets specification and customer requirements Ensures that all product undergoes effective visual inspection, release checks and has been manufactured in compliance with GMP and quality system requirements Establishes and maintains an effective change control process to ensure that all changes are assessed for their impact to regulatory compliance and product safety, in accordance with the quality system and appropriate controls are established to facilitate compliant management of the change. Ensures all complaints reported by customers are appropriately documented and investigated as required and that any complaints that may result in Field Action immediately to the Unit Manager and Senior UK or European Quality Management Representatives Ensures all documentation is relevant and applicable to the process and is reviewed and updated. Chair monthly quality review meetings ensuring outcomes, decisions and actions of the review are documented Report weekly / monthly quality KPI to Senior Management Establishes and manages the site nonconformance process in compliance to GMP regulation and Corporate procedures ensuring that all deviations from documented processes are recorded and investigated Ensures no product is released before a formal assessment for the impact of the deviation is made and a disposition approved Ensures formal CAPA’s are raised to investigate and act to address deficiencies in the quality system, processes or product quality, or to make improvements to the quality system Oversees the calibration, validation and maintenance programs on site and ensures that validation is managed in a compliant manner Ensures that calibration and maintenance occur in a timely manner and any failures or deviations are escalated, assessed and escalated as necessary Ensure all manufacturing operations and associated facilities and equipment comply with current GMP guidance Supports training and communication of GMP requirements to engineering staff and contractors Oversee the site audit readiness program ensuring that the site had a process for internally reviewing the compliance status and is prepared for an audit at any time Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance Ensures staff understand their responsibilities under the quality system regulations Ensures that training is conducted with staff to enable them to complete their jobs in compliance with the Baxter quality systems and country regulations Communicates changes of the quality system to staff, ensuring appropriate training programs are executed. Qualifications Degree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology / Engineering A strong understanding/background of working in aseptic manufacturing At least 3 years in a leadership position A strong background in QA / similar position