Quality Associate – Melbourne biotechnology company

Posted: 7 March 2022

The Client

The client, a Melbourne based biotechnology company, has developed a unique world leading platform technology that enables site specific drug delivery. Their technology involves development of patented polymeric prodrugs that can be engineered into various product forms. The company now seeks to build on its capabilities to continue their transition from R&D to clinical development.

The Role

Reporting to the Head of Quality Assurance, the successful candidate will be responsible for assuring management of the Quality Management System (QMS). You will assist with the building, development, and maintenance of the QMS to be compliant with Good Laboratory Practices(GLP) and pharmaceutical Good Manufacturing Practices (GMP), locally and internationally.

  • Implement, maintain, review, and update the Quality Management System.
  • Assist in deployment and operationalisation of a new electronic quality management system and assist with its validation.
  • Implementation, control, and management of all quality system documents.
  • Maintain regulatory compliance for the quality systems and ensure readiness for regulatory audits.
  • Review and approve master batch records and executed batch records.
  • Review, maintain and approve all deviations, ensuring that any actions from the deviations are closed within agreed timelines.
  • Respond to, participate in and may lead investigations and corrective action implementation for identified quality issues including internal/external audit actions.
  • Review and provide QA input into all internal and external change requests for GMP compliance.
  • Review, maintain and approve all document change controls, ensuring that any changes are closed within the agreed timelines.
  • Ensure effectiveness checks are completed on all CAPAs.
  • Maintain knowledge and oversight of the relevant national and international standards for TGA, EMA, FDA, ICH and PIC/s.
  • Proactively review systems and processes to identify areas of review, improvement, simplification, or change.
  • Assist with the writing of other documentation e.g. manuals, standard operating procedures and validation documents.

Expertise Required

  • Bachelor’s degree in science/ chemistry/ pharmacy or similar
  • 2-5 years’ experience in a pharmaceutical quality system management role in a GMP environment
  • Experience writing SOPs, protocols, and technical reports for a pharmaceutical and/or medical device company.
  • Ensure data quality, compliance, and consistency of document standards.
  • High level Microsoft Office skills – in particular with MS Word, MS Excel and MS PowerPoint.
  • Experience in preparation of regulatory documents such as NDAs, INDs, briefing documents, Investigator Brochures would be desirable
  • Attention to detail – accuracy and correctness of content in any document.
  • Able to participate in projects and initiatives across multiple functional areas.
  • The ability to be flexible, persevere and work independently as well as a multidisciplinary team.

The Application

Our client is at the frontline of the development of new innovative technologies. This is an exciting time to join as the business transitions on an ambitious growth strategy, including a new state of the art facility.

To join our client in this exciting opportunity, please email your cover letter & CV to careers@mexec.com.

Confidential enquiries to Marilyn Jones on 1300 0 MEXEC

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