Benefits

• Working within a global team
• Must have unrestricted work rights/ be able to work unrestricted for 6 months.

About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.

About the role
An exciting opportunity for an experienced Senior Validation Specialist to join the Analytical Science & Technology (AS&T) team. This is a pivotal role where you will act as a Subject Matter Expert (SME) in analytical testing methodology, driving method validation, standardization, and robustness across sites. You will also play a key role in troubleshooting technical issues and implementing the latest testing technologies.

Key Responsibilities

• Maintain compliant Quality Control (QC) method validation lifecycle management.
• Lead troubleshooting investigations for QC test methods and implement solutions through CAPA and Change Control.
• Oversee method standardization and robustness programs.
• Develop and enhance analytical test methods, keeping pace with industry advancements.
• Coordinate and execute intra-site method transfers and provide SME input into regulatory filings and audits.
• Design and execute experimental projects involving new analytical technologies.
• Manage and oversee AST project studies, ensuring quality and compliance.
• Review validation data, identify trends or deviations, and escalate issues to management as necessary.
• Influence QC leadership on method improvement and replacement strategies.
• Maintain up-to-date industry knowledge on emerging methods, equipment, and best practices.

Requirements

• Bachelor’s degree in a Science-related field (Chemistry, Biochemistry, or related discipline).
• Minimum 2 years’ experience in pharmaceutical or biopharmaceutical industries, with increasing responsibilities in Quality Management.
• Background in method development and experience in a microbiology setting
• Strong cGMP knowledge and background in Pharmaceutical Quality Control.
• Hands-on experience with analytical testing techniques and regulatory compliance.
• Excellent time management and ability to plan and oversee work schedules.
• Strong communication skills (written & verbal) for documentation, reporting, and collaboration.
• Knowledge of continuous improvement and root cause analysis methodologies.

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

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