Our client is a Melbourne-based, ASX-listed biotechnology company, who has developed a polyclonal antibody platform and novel class of antibodies that can address unmet medical needs.
Reporting to the Director of Quality, the successful candidate will be responsible for ensuring ongoing management of the Quality Management System (QMS). This will also include other responsibilities across the business, presenting a great opportunity to learn operational and strategic principles as part of a small team. With a positive attitude and growth mindset, you will contribute across the company and develop new skills and experience.
Maintain, review, and update the Quality Management System. QMS – to be compliant with Good Manufacturing Practices (GMP), locally and internationally.
Review, maintain and approve all deviations, ensuring that any actions from the deviations are closed within agreed timelines.
Respond to and participate in investigations and corrective action implementation for identified quality issues including internal/external audit actions.
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.
Assist with the writing of other documentation e.g. manuals, standard operating procedures and validation documents.
Assist in customer service and Pharmacovigilance activities as required.
Bachelor’s degree in science/ chemistry/ pharmacy or similar
0-3 years’ experience in a pharmaceutical quality system management role in a GMP environment desirable
Experience writing SOPs, protocols, and technical reports for a pharmaceutical and/or healthcare 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.
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 in small multidisciplinary team.
You understand what Customer Service really means.
Your willingness to say. ‘I don’t know, but I am willing to learn.’
To join our client in this exciting opportunity, please email your cover letter & CV to Mark Thomas or Marilyn Jones at email@example.com.
Confidential enquiries to Mark or Marilyn on 1300 0 MEXEC