Job Description

Sterility Support & Validation ManagerThe main purpose of the Sterility Support & Validation Manager is the management of the validation section and co-ordination of the total validation project.General DutiesValidation Section ManagementGeneral Section Management, i.e., Activity planning, co-ordination, execution and control (Project Management)Maintenance of department efficiency through principles of supervision and management.Acting as communication link between staff members and other departments and ManagementManagement and oversight of technology transfer activities (e.g., a commission of a new product and design element responsibility).Systems maintenanceSuch that the plant is able to satisfy regulatory authorities and Inspection bodies of necessary validation measures for continued business and securement of new business.ValidationResponsible for implementation of a Risk Based Approach to all Validation and Qualification activities.Ensure that all Validation and Qualification activities are managed and carried out according to GMP requirements.Prepare and manage the Validation Master Plan which includes all equipment and process validation, utilities, computers and other related areas.Overall responsibility for the development, preparation and implementation of written procedures, URS, DQ, IQ, OQ, PC, protocols and reports relating to Validation, Qualification and Calibration, inclusive of production, warehouse and laboratories.Liaison with QA and Regulatory Affairs Department regarding process /validation requirements and the co-ordination thereof.Ensure all Validation activities are managed and carried out according to GMP requirementsPresent and justify validation scope and documents to both internal and external auditorsSystem evaluationGeneral process evaluation. This includes reporting of observed deficiencies to the correct persons and follow up on corrective action liaising with Production where necessary.Monitoring and auditing compliance to both regulatory requirements and in-house standards regarding current Good Manufacturing Practices.Shared responsibility for the investigation into and solution of process and quality problems as well as preventative planning and action.Carry out other tasks within the department/ factory which are consistent with the grade, qualification and training of the incumbent.QualityResponsible to conduct investigations and root cause analysis through KabitrackBudget and Cost ControlControl and optimise the cost within the departmentSet quality and performance KPIs 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 improvementsHuman 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 PolicyRequirementsA Life Science or Engineering degree or equivalent.5-10 years of direct Validation Management experience in the pharmaceutical industry.Project Management skillsUnderstanding and network in Regulatory Authorities and InspectionsRisk assessment and evaluation methodologyGood Manufacturing Practice RegulationsProcedures and DocumentationAudit experience, initiating, performing and following upFinancial skills to control and optimize costsContinuous improvement methodsValidation & Qualification requirements

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