Validations and Equipment Officer

3 weeks ago


Centurion, South Africa Sentinel Staffing Services Full time
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
.

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