Divisional Manager: Quality Assurance

Pharma Dynamics

Western Cape, South Africa

Permanent

Jul 20

We seek to appoint an experienced and seasoned Divisional QA Manager to manage all aspects of the Quality Assurance department by leading a cross-functional Quality Assurance team and providing oversight in relation to QA operations and systems management according to the relevant GMP standards KEY RESPONSIBILITIESStrategy and DevelopmentContribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performanceContribute to new business initiatives and projectsMaintain and manage the impact of potential product and business risk on Quality Management Systems (QMS)Responsible for achieving budget and forecastOperational management of the QA Department:Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule.Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.Liaising with suppliers and distributors with regards to quality issues and complaintsReviews and approves finished product specifications.Identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.Provides oversight and works directly in daily operations and systems within the Quality Assurance program to assure completions of activities on time and in compliance to regulatory guidelines.Monitors non-conformances or anomalies to the guidelines and GMP principles and provides timely input to ensure proper completion.Manage the adherence to an annual audit planAssesses and reviews the impact of excursions and deviations throughout the manufacturing and packing process.Maintains internal and external relationships.Assist with training in line with departmental training program when required.Implement and manage new and ongoing stability programsManagement of departmental budgets in line with organizations financial objectiveGood Manufacturing practice (GMP, GLP, GWP)Maintaining and coordinating all GMP principles Conduct risk assessments on a regular basisMonitor and approve temperature excursions during product transportationProvide Regulatory support relating to compliance and all GMP activities that might impact the dossier or SAHPRA/PIC/s.Documentation & Systems ManagementDocumentationManaging the accuracy and completion of all databased entries, registers and formsManages the implementation of new products in line with QA requirements Manage annual product reviews, risk management reports and adherence to master documents and SOPsRecord and interpret statistical information and trendsManage the implementation of technical agreements Compiling and presenting management review reports to the EXCOSystems Drive operational efficiency by ensuring fit for purpose QMS Ensure ongoing compliance with the Quality Management System Develop, implement, and monitor overall process mapping for quality improvement purposes and electronic database managementPersonnel ManagementSetting up goals and objectives in alignment with Scientific Affairs departmental strategiesConducting Performance management and appraisalsManage conflicts when necessaryMentoring and coaching and developing of direct reports

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Pharma Dynamics

Pharma Dynamics is a leading pharmaceutical company. We are one of South Africa's largest generic medicine providers and the country's leading provide...

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