Validations and Equipment Officer

Description:

Our client is a well-established medical group of companies in Irene, Centurion. They are looking for a Validations and Equipment Officer to join their dynamic team. 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
.

Requirements:

• 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

• 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.