ENVIRONMENT: Our client, rooted in biotechnology since 1987, maintains a steadfast commitment to producing implant devices of the highest quality and biocompatibility standards. They are currently seeking a Validations and Equipment Officer responsible for conducting process validations, equipment qualifications, and organizing calibration for measurement equipment. Applicants must hold a tertiary degree in natural sciences or engineering, with a minimum of two years of relevant experience. DUTIES: Writing and execution of validation protocols. This will Include but is not limited to: Process, Packaging, sterilization and cleaning validations. Writing and executing equipment qualification protocols. (IQ, OQ, PQ). Download data logger files, trend and report on data. Maintain temperature logger batteries. Reporting the results and outcomes of validation plans. Ensuring that the master validation plans are maintained and that validations are monitored and processes are re-validated as per the master validation list. Manage the equipment calibration schedule by ensuring the calibration activities of all inspection, monitoring and testing equipment are completed on time. Manage and equipment list and ensuring that new equipment is added onto the list after the equipment has been qualified as per protocol. Execute environmental monitoring activities according to the quality schedule. Arrange and send out quarterly product testing samples to external testing labs. Perform periodic packaging verifications and facilitate aseptic process simulations. Ensure all activities performed has been recorded and maintained according to company procedures and requirements. To participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness. To participate in audits and inspections as required. To support day-to-day activities associated with maintaining QMS compliance as directed by the Head of Regulatory and Quality. REQUIREMENTS: Required minimum education: Tertiary degree required in the natural sciences or engineering Required minimum experience: 2 years Good understanding of statistics Computer literate: Microsoft Office ATTRIBUTES: Good communication skills – writing, presentation and interpersonal communication (Good writing skills a fundamental requirement). High ethical standards
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