Validations and Equipment Officer
3 weeks ago
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 standards
- Good understanding of statistics
- Computer literate: Microsoft Office
Primary 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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