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Sterility Assurance Specialist

Job description

Benefits
  • Working within a global team
  • Must have unrestricted work rights/ be able to work unrestricted for 7 months
About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.

About the role
As a Sterility Assurance Specialist, you will report to the Sterility Assurance Monitoring Team Lead and play a critical role in maintaining and enhancing sterility assurance controls. Your expertise will ensure the highest standards in environmental and personnel monitoring, in-process testing, finished product testing, and microbiological method development.

Key Responsibilities:
  • Oversee the lifecycle management of sterility assurance monitoring controls.
  • Conduct Environmental and Personnel monitoring, in-process testing, and finished product testing.
  • Participate in the validation and qualification of the facility, utilities, equipment, processes, personnel, and methods.
  • Lead initiatives in cleaning, disinfection, hygiene, operator training, gowning, and facility design.
  • Collaborate with global function leads and site leadership to ensure continuous adherence to regulatory and company standards.
  • Drive continuous improvement in sterility assurance governance.
  • Manage trending and data analysis for sterility monitoring.
  • Act as the point of contact for a bulk facility, managing stakeholder relationships and driving project goals.
Must have:
  • Bachelor of Science (Microbiology preferred) or relevant scientific degree.
  • Experience in Aseptic manufacturing, ideally within the pharmaceutical industry.
  • Expertise in Environmental Monitoring, Sterility Assurance, GMP, and GDP.
  • Ideally seeking someone who has worked in Pharma industry
  • Proficient in data management and trending analysis.
  • Excellent stakeholder management and communication skills.
  • Ability to work autonomously and drive sterility assurance projects to completion.
Culture
Although a large, global company, they are able to provide a family-like culture and prides itself in improving the lives of others.

How to Apply
Click apply or contact Georgia Graham – Senior Recruitment Consultant on 03 7037 1653 for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.
  • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific
  • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs
  • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse
  • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing
For more job opportunities, visit www.hpgconnect.