+ 27 (0) 21 741 0400 + 27 (0) 21 741 0400   CAREERS@DATAFIN.COM

Validation and Equipment Officer

Supply Chain/Logistics
Pretoria/Centurion – Gauteng

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 

+ 27 (0) 21 741 0400