Job Description

Validation Manager - Port ElizabethFull job descriptionOverviewControl and manage validation function to ensure equipment is validated in compliance with GMP/ regulatory requirementsProvide technical support, process control and process improvement activities to support validation activitiesManage and guide the unit through team leadersPerformance management of direct reports and unitResponsibilitiesPlanning and Unit ManagementProvide technical and operational input during the drafting of processes, policies and procedures for unitMonitor implementation of operational plan by teamManage operational budget of the unitEnsure availability and optimal allocation of resources to achieve operational objectivesPerform human resource functions for optimal management of unitValidationEnsure validation plans, SOPs and protocols are compiled and implemented to always ensure continued complianceManage validation activities within value stream validation programme according to validation plan/ scheduleEvaluate results from executed validation protocolsEnsure validation protocols and validation reports for new equipment / systems are documented and compiledDevelop and implement re-validation plansMaintain and audit compliant state of validation departmentReview validation training requirements and implement training where necessaryQualificationManage qualification activities with QC and ProductionReview and approve relevant qualification protocols as per SOPManage change controls to ensure compliant status of affected equipment is not compromisedEnsure documents and procedures to operate and maintain equipment are in placeRequalificationReview and approve re-qualification of equipment and utilities as per Protocol and SOPGovernance, Risk and ComplianceOversee compliance within strategic and operating guidelines and policies for department(s)/ function(s)Ensure recordkeeping complies with legal requirements and provide input into changes to policies in this regardProvide recommendations for development of risk-based compliance systems in order to improve overall compliance performance of the organisation and/or department/function. RequirementsBackground/experienceMinimum of Bachelors Degree and10 years related experienceManagement experienceExperience in validation techniques in a Pharmaceutical IndustrySpecific job skillsAdvanced understanding of Qualification and Validation principlesKnowledge of control, instrumentation and electrical systemsUnderstanding of pharmaceutical manufacturing and corrective action programsPharmaceutical standards and compliance requirementsAbility to interpret and implement policies, processes and objectivesCompetenciesTranslating strategyInterpreting and internalising informationInterrogating informationOffering insightsManaging performanceAccountability & Decision RightsDevelop, communicate, manage and implement corporate and divisional strategic plans and budgets, policies and proceduresIndependent Decisions relating toDesign and implementation strategy for programmes and processesInterpretation and execution of and recommendations on policy/ procedure related modificationsShort- and long-term department schedules, quality, compliance and resource allocationOperational objectives and work plans, and delegation of assignments

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