Robert Shearan Email & Phone Number

Canberra, Australian Capital Territory, Australia

• The Inspections Section is responsible for the assessment of manufacturers of medicines and blood, tissue and cellular therapies for compliance with applicable regulatory requirements and product standards. These.
• Plan and lead inspections of establishments involved in the manufacture of therapeutic goods to assess compliance against established standards.
• Lead the preparation of and prepare high quality reports that document inspections, their findings and recommendations on the suitability of licensing.
• Contribute to the development of risk-based approaches to guide the Section’s approach to inspections and compliance management.
• Conduct all work in accordance with standard operating procedures and within required timeframes.
• Undertake complex analysis and interpretation and apply judgement to assess evidence of manufacturers’ compliance with applicable regulatory requirements and product standards.

Canberra, Australia

• The Recalls Section is responsible for coordinating and managing recall actions for defective or unsafe therapeutic goods in Australia following the provisions of the Uniform Recall Procedure for Therapeutic Goods.
• Supervise and manage staff performing the day to day work activities of the Recalls Section.
• Assess, manage and coordinate complex or sensitive recall actions for therapeutic goods in accordance with the (URPTG).
• Provide expert technical advice and assistance to team members.
• Engage and collaborate with key internal and external stakeholders to achieve outcomes and facilitate cooperation in the national approach to therapeutic goods recalls.
• Oversee the general management and administrative tasks within the Section, stakeholder engagement roles and assist with the mentoring, training and development of team members.

• ASEPTIC COMPOUNDING TECHNICIAN Compounding patient specific chemotherapy drugs (Clean Room Compounding)
• Aseptic preparation and mixing of intravenous medications, such as cytotoxic chemotherapies, monoclonal antibodies, clinical trials and other parenteral compounds.
• Includes packaging and labelling patient specific medications.
• Working with hospitals to ensure the best possible patient treatment and support Quality assurance, facility maintenance and good manufacturing practice
• Keeping accurate medication, patient and hospital records.
• Performing internal audits of cleaning, manufacturing and packaging processes.

Norwest Business Park

Compounding patient specific chemotherapy drugs, keeping accurate medication records and working with different insurance, medical providers and hospitals to ensure the best possible patient treatment and support at every step. One of the main duties include packaging and labelling patient specific medications; in addition to preparing and mixing.

Certificate Iv, Government Investigations (Regulatory Compliance), Competent

Uphold and support the values and principles of public service Plan and initiate an investigation Conduct an investigation Finalise an.

Master'S Degree, Medical Statistics

The program has been designed to provide advanced biostatistical training for a diverse range of students. The main thing is that you.

Bachelor'S Degree, Biotechnology

Activities and Societies: UTS Ultimate-Frisbee Team, Electronic Gamers Guild, Head-Bangers Society (Heavy Metal Supporters), UTS.