PSC002821—Nuclear Medicine Manufacturing Facility - Safety Analysis Report

The Australian Nuclear Science and Technology Organisation (ANSTO) seeks to engage a suitably qualified and experienced consultant to provide Safety Analysis Report (SAR) consulting services for the Nuclear Medicine Manufacturing Facility (NMMF) project at Lucas Heights, NSW. The NMMF will replace ANSTO's existing radiopharmaceutical manufacturing facility and support the long term supply of nuclear medicines for Australia. The successful consultant will be responsible for developing, coordinating and maintaining the overarching Safety Analysis Report (SAR) and associated Plans and Arrangements (P&A) required to support staged regulatory licence applications to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). Services include development of regulatory submission documentation, integration of safety inputs from multiple design consultants and stakeholders, management of review and approval processes, preparation of supporting regulatory forms, and support for ANSTO during licence assessments and approvals. The consultant will work collaboratively with ANSTO consultants and other project stakeholders to develop a comprehensive safety case for the facility in accordance with applicable ARPANSA regulatory guidance and ANSTO requirements. Detailed scope is outlined in the attached specification. The services are expected to support multiple licence application packages associated with the design, construction and operation of the NMMF, a nationally significant nuclear medicine manufacturing facility.