Job Description

Quality Assurance Manager - Port ElizabethFresenius Kabi is a global healthcare company more than 40,500 employees worldwide.We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.The main purpose of the Quality Assurance Manager is Managing quality within the business to achieve the quality objective reliably through a comprehensively designed and correctly implemented system of quality assurance, incorporating good manufacturing practice. General DutiesParticipation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvementParticipation in external audits and inspections to ensure a positive outcomeResponsible for Internal audits and self-inspection programs to ensure that FKMSA operates in compliance with both regulatory requirements and in-house standards, regarding Current Good Manufacturing Practice.Pro-active contribution in the handling of product failures and anomalies - Investigation into causes, implementation of corrective/preventive action and recording and trending of data.Ensure appropriate management systems are in place for data related to deviations, process deviations, trending of deviations, OOT, OOS, Root Cause Analysis, CAPA, Change Control, Risk Assessments, Customer Complaints, PQR and all other Quality data and documents. and that systems are being adhered to in accordance with GMP and Corporate standards.Management of customer complaints from the market ensuring they are handled effectively and efficiently. This includes, but is not limited to, the investigation into causes, implementation of corrective/preventive action and written and/or verbal response to marketing and customers. Recording and trending of complaint data and issuing of reports.Ensure that GMP relevant Management documents (SMF and QM handbook) are up to date, implemented and followed.Ensure that GMP relevant documents (SOP and Specifications) are in compliance with current GMP requirements and corporate guiding documents.Ensure that GMP relevant Management documents (VMP) are up to date, implemented and followed.Provide system for control of global Documents and related training.Ensure that Continuous Improvement programs for Quality Management areasReview and approval of annual Product Quality Reviews for all products.Ensure trending & statistical evaluation of GMP relevant data is performed and used for quality improvements and root cause analysis for complaints, deviations, OOT and OOS.Ensure that training of operators and staff is appropriately performed and efficient.Ensuring the qualification and maintenance of the department, premises and equipment.To ensure that the required initial and continuing training of the department personnel is carried out and adapted according to need.The authorization of written procedures and other documents, including amendmentsProviding a Training Management System for the training of all staffThe approval and monitoring of contract manufacturers and providers of other related outsourced activitiesTo oversee the vendor management programPerform GMP Compliance training (on the job)Provide support during Mock recallResponsible to conduct investigations and root cause analysis through KabitrackTo oversee the preparation and management of all Printed Packaging Material function in line with SAHPRA requirementsProviding a system for the retention of recordsManagement of quality systems and related standard operating practices.Participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvementParticipation in external audits and inspections to ensure a positive outcomeResponsible for Internal audits and self-inspection programs to ensure that FKMSA operates in compliance with both regulatory requirements and in-house standards, regarding Current Good Manufacturing Practice.Pro-active contribution in the handling of product failures and anomalies - Investigation into causes, implementation of corrective/preventive action and recording and trending of data.Ensure appropriate management systems are in place for data related to deviations, process deviations, trending of deviations, OOT, OOS, Root Cause Analysis, CAPA, Change Control, Risk Assessments, Customer Complaints, PQR and all other Quality data and documents. and that systems are being adhered to in accordance with GMP and Corporate standards.Management of customer complaints from the market ensuring they are handled effectively and efficiently.This includes, but is not limited to, the investigation into causes, implementation of corrective/preventive action and written and/or verbal response to marketing and customers. Recording and trending of complaint data and issuing of reports.Ensure that GMP relevant Management documents (SMF and QM handbook) are up to date, implemented and followed.Ensure that GMP relevant documents (SOP and Specifications) are in compliance with current GMP requirements and corporate guiding documents.Ensure that GMP relevant Management documents (VMP) are up to date, implemented and followed.Provide system for control of global Documents and related training.Ensure that Continuous Improvement programs for Quality Management areasReview and approval of annual Product Quality Reviews for all products.Ensure trending & statistical evaluation of GMP relevant data is performed and used for quality improvements and root cause analysis for complaints, deviations, OOT and OOS.Ensure that training of operators and staff is appropriately performed and efficient. Budget and Cost ControlControl and optimize the cost within the departmentSet quality and performance KPIxe2x80x99s for the department and monitor the departmental performance on a defined frequencyContinuously improve processes to introduce World Class Manufacturing practices within the businessIdentify opportunities for productivity and efficiency improvements Human Resources ManagementManage all personnel in the department including disciplinary proceduresEnsure that all personnel in the department is developed and trained as required by the various job functionsRecruitment of staffStaff development regarding identifying needs and opportunitiesPerformance Management evaluationReview salaries and promotions if applicableImplementation of equity plan as set out in the Employment Equity Policy BSc. Micro/Chemistry/Biotechnology or B PharmDirect experience within the pharmaceutical sterile manufacturing environment is essential5-10 years of previous pharmaceutical experience within a Quality Assurance functionExperience/ strong interest in product problem solving and product research and developmentManagement experience within manufacturing environmentGMP trained/certified

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