Validations And Equipment Officer

Qualifications: Tertiary degree required in the Natural Sciences or Engineering
Minimum of 2 Years working experience
Competencies:Good communication skills in writing, presentation, and interpersonal communication (Good writing skills is essential)High ethical standardsGood understanding of statisticsComputer literate: Microsoft OfficePrimary Responsibilities: Writing and execution of validation protocols. This will Include but is not limited to: Process, Packaging, sterilization, and cleaning validations.
Conduct equipment qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Download data logger files, monitoring trends, and generating reports.
Maintain temperature logger batteries.
Document and communicate the results and conclusions of validation plans.
Ensure the upkeep of master validation plans, monitoring validations, and initiating re-validation processes according to the master validation list.
Manage the equipment calibration schedule, ensuring timely calibration of all inspection, monitoring, and testing equipment.
Maintain an updated equipment list, adding newly qualified equipment 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.
Maintain comprehensive records of all activities in accordance with company procedures and standards.
Participate in continuous improvement processes for simplifying validation and manufacturing related processes while also driving improvements in quality and validation effectiveness.
Participate in audits and inspections as required.
Support day-to-day tasks related to maintaining Quality Management System (QMS) compliance as directed by the Head of Regulatory and Quality.
Working hours are Mondays to Fridays from 07:00 to 16:00 (With overtime on demand)
The role is available to start as soon as possible, preferably by 1 June 2024
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