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Validation Coordinator (Utilities) - Midrand

Provide technical support to all departments in accordance with established Service Level Agreements and company standards.Responsible for ensuring that qualification of utilities is carried out in accordance with manufacturing procedures and policies, cGMP, and relevant guidelines.Generate, execute and/or review completed qualification protocols and associated data for conformance to applicable acceptance criteria.Coordinate timely completion of utilities qualification in support of manufacturing activities and Regulatory requirements (writing, reviewing and execution of qualification protocols and reports). Minimum Requirements: Bachelor’s degree Mechanical/ Electrical Engineering /Biotechnology /BiochemistryExperience in pharmaceutical industry experience, with at least 3 years in Validation/ Qualification/ Utility supportKnowledge of HVAC, Water for Injection, Purified Water, Compressed Air and Clean Steam and Nitrogen systemsDemonstrate ability to provide technical solutions for complex problems through qualification knowledge.Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.In depth understanding of utilities and engineeringExcellent communication and interpersonal skillsAbility to work independentlyOvertime from time to time will be required so flexibility will be important. Core Competencies: Relating and networkingPresenting and communicating informationWorking with peopleDeciding and initiating actionDelivering results and meeting customer expectationsPlanning and organisingWriting and reportingApplying expertise and technologyCoping with pressure and setbacksAchieving personal work goals and objectivesAdhering to principles and values https://protool.gumtree.co.za/external-link-browser.html?urlaHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yNjA1OTEwMTk0P3NvdXJjZT1ndW10cmVl&jid1245770&xid2605910194 Apply Now
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