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