This position is responsible for all the Validation of TSI Pharmaceuticals' (TSIP) activities associated with facility, equipment, and processes.
The position supports Quality Management Systems, processes and procedures and ensures compliance with necessary regulations / requirements and delivers consistent quality to the business.
1.JOB PURPOSE
This position is responsible for all the Validation of TSI Pharmaceuticals' (TSIP) activities associated with facility, equipment, and processes.
The position supports Quality Management Systems, processes and procedures and ensures compliance with necessary regulations / requirements and delivers consistent quality to the business.
2.PRINCIPAL RESPONSIBILITIES / ACCOUNTABILITITES
Validation
Maintenance / coordination of all Validation activities regarding:
Equipment / Facility Validations
Process Validations
Cleaning Validations
Computer Validations
Support Operations and Quality in Project Management activities, including review of timelines and required resources
Support / advice to the Quality and Operation team in process and procedural implementation related to Validation, including training.
Quality and GMP
Assure compliance with TGA & cGMP and other regulations
Complete GMP documentation to required standard and follow SOPs
Laise with QA and Operations to implement, maintain and improve systems that assure regulatory compliance
Investigate, complete root cause analysis, risk assessments, deviations as required
Technical Support / Advise
Provide all necessary technical support and regulatory advice wrt.
validation requirements and activities
Manage all validation activities, including generation and execution of protocols and schedules
Maintain Validation Register, including Periodic Reviews requirements




Ensure all Validation activities are completed on time and as per Project Timelines
Provide advice to QA and Operations, regarding investigations, product/processes, and other matters as required
Leadership and Teamwork
Promote GMP and Quality, Right First Time, Every Time, across all areas of TSIP
Work closely with all departments to achieve required outcomes
Operational deployment in line with TSIP Occupational Health and Safety Policies and Procedures
Participate in miscellaneous tasks as delegated by the Quality Assurance Manager.
3.ORGANIZATIONAL CHART
Reporting line: Quality Assurance Manager
4.KEY SELECTION CRITERIA
Qualifications and Experience
Diploma or Degree in Science, engineering or related discipline, preferred.
A minimum of 3 years' experience in a similar role in a regulated environment i.e., Pharmaceuticals / Therapeutic Goods (Complimentary Medicine), including hands-on validation experience
Strong relationship building abilities with internal/external stakeholders
Demonstrated ability to communicate (both orally and written) with all levels within internal and external to the company
Preferred Skills
GMP principles and other relevant TGA regulations applicable to Therapeutic Goods and Food supplement products.
Communication
Robust verbal & written skills
Problem solving, with strong analytical ability to quickly gather facts, draw conclusions and propose solutions
Balancing dynamic priorities, challenging timelines, complex problem solving, technical planning and organizational skills
Attitude
Positive, approachable, and punctual
Professional, proactive, and responsible
Demonstrates an effective "Can Do, Will Do," "Right First Time, Every Time" professional mindset in a dynamic, multi-cultural environment.
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📌 Validation Specialist (Brisbane)
🏢 TSI Pharmaceuticals
📍 Brisbane