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Validation Specialist

About The Company
KE Select has exclusively partnered with Specialty Probiotics Australia to support the scale-up of their team. They are a newly formed company with the benefit of acquiring the assets of a previous probiotics manufacturing facility and new majority ownership from a highly successful leader in this niche area.
Based in Ormeau, the Queensland facility will be sourcing new and innovative strains of microbiomes to produce world-class probiotic ingredients and products.

In addition to probiotics, there are plans to produce postbiotics ingredients for both human and animal nutrition products. Investment plans are in place to upgrade production capability over the next few years, allowing new packaging formats, dosage, and higher concentrations. Specialty Probiotics Australia aims to turn probiotic ideas into reality for their customers, providing solutions from formulation through to manufacturing.

With an exciting growth trajectory expected, and a core team of highly experienced leaders in the probiotic field, now is the time to join and contribute to the early-stage development of this company. We are looking for individuals with experience from a GMP and TGA-certified environment with a passion for supporting health and wellness needs.

Reporting to the General Manager, the validation specialist will be responsible for driving the validation programs - equipment, process and cleaning validations. 

Key Responsibilities include: 
  • Preparation, review or approval of validation protocols.
  • Supervision of the execution of the validation protocols raised internally or by external engineers/consultants.
  • Work in collaboration with the QA/QC to ensure timely delivery of testing results for validation activities.
  • Work in collaboration with quality and manufacturing 
  • Ensure corrective actions are appropriately developed and implemented in a timely manner.
  • Preparation of reports, maintenance of the validation and schedules for review
Key Criteria include:
  • Previous experience in a similar role - implementing, managing and enhancing quality standards within GMP and TGA guidelines. 
  • Self-driven - leading qualification and validation activities 
  • Demonstrated experience doing data analysis 
  • Strong understanding in a similar environment - pharmaceutical, scientific 
  • Relevant qualifications in a scientific, pharmaceutical or engineering 
  • Strong understanding of Quality Management Systems 
  • Flexibility with changing environments 
Full-time onsite position in Brisbane. 

Exciting new role to join the team and be part of the growth. Supportive and collaborative team culture and looking for someone to join the team. 

KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Medical Device and Clinical space.
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