Job Description

Validation Officer - Port ElizabethFull job descriptionJob purposePerform validation exercises of production and lab equipment, utilities, packaging, and processes to ensure specific standard of compliance is met.ResponsibilitiesPlanning and Operational SupportAct as a technical/ subject matter resource.Facilitate implementation of current processesIdentify gaps in current policies and procedures.ValidationPerform validation exercises in compliance with GMP standards and validation schedules.Maintain compliant status of equipment and processes.QualificationPerform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended use.Perform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limits.Investigate and report OOE results and perform re-tests.Participate in change control assessments to ensure compliant status of affected equipment is not compromised.Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered toEnsure documents and procedures to operate and maintain equipment are in place.RequalificationAssess and recommend re-qualification of equipment and utilities as appropriate as per Protocol.Prepare and perform re-qualification of equipment and utilities as per SOP.Reporting and record-keepingCompile, maintain and update validation documentation as per SOP and QMSGenerate validation reports on weekly/monthly basis Background/experienceNational Certification (N4-N6) or Trade Tested Artisan with 2-4 years related experiencedegree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experienceAseptic pharmaceutical manufacturing process and automated packing experienceSpecific job skillsTime management: handling multiple tasks at once.Good interpersonal and presentation skillsCustomer champion: Excellent relationship building internally and externally.Detail orientated.Information seeking: Process improvement initiative.Team playerCompetenciesInnovationTeamworkAttention to detail.Information gatheringTacking ActionPlanning and OrganizingAspen knowledgeOptimism

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