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Quality Assurance Officer
4 months ago
Location: Brisbane QLD
Employee Status: Full-time
**Salary**: Above $70,000 FTE
- Support the delivery and management of pioneering pharmaceutical products
- Growth opportunities to advance your career
- Join a collaborative team environment, with flexible working arrangements
Support the quality and compliance processes for an innovative life sciences company focused on the development and commercialisation of pharmaceuticals.
**What you can achieve in the Position**
QBiotics Group is an Australian-owned life sciences company that discovers and develops plant-derived cell signalling molecules to address challenging medical conditions in humans and companion animals.
In the position of Quality Assurance Officer, you will work in partnership with the Quality Assurance Manager and our in-house and contracted development teams. You will be responsible for planning, organising and coordinating the deployment of the organisation’s quality systems and processes, with specific tasks including:
- Reviewing raw materials, API and drug product manufacturing batch documents;
- Performing investigations;
- Reviewing packaging material artworks;
- Maintaining the electronic Quality Management System (eQMS);
- Preparing quality management reviews;
- Supporting the review of quality agreements;
- Supporting the preparation of annual product quality reviews;
- Reviewing stability data;
- Reviewing and updating SOPs and other quality system documentation,
- Advising on and delivering training relating to quality programs and objectives;
- Supporting corporate quality activities and;
- Performing other technical tasks as required.
**Required Skills and Experience (Selection Criteria)**
- Bachelor’s degree in a scientific discipline (i.e., biopharmaceutical or biomedical science, chemistry, pharmacy or another relevant life sciences degree);
- Have two years post-qualification work experience within quality assurance and compliance areas of a pharmaceutical organisation, with at least one year in a sponsored environment;
- Demonstrate quality experience in sterile products for commercial and investigational use;
- Demonstrate experience in managing and maintaining an electronic Quality Management System;
- Demonstrate experience in the development, implementation and review of policies, procedures and work practices relating to manufacturing and corporate quality assurance.
- Demonstrate experience in conducting and reporting quality-related investigations and root cause analysis;
- Demonstrate experience in preparing change control records;
- Demonstrate experience in manufacturing batch record reviews;
- Demonstrate experience in supporting supplier qualification processes, including auditing and preparation of audit reports;
- Demonstrate experience in the Microsoft Office suite, including SharePoint Online.
- Highly effective oral and written communication skills, including the ability to prepare high quality documents and reports, and present information in a concise and articulated manner;
- Proven ability to work in a team and a collaborative work environment.
As a proactive individual, you will possess a positive, assertive and flexible attitude, with the ability to build and maintain successful working relationships across a range of stakeholders. You will be a hands-on self-starter with excellent communication and interpersonal skills. Your ability to successfully manage multiple tasks, shifting priorities and maintain excellent attention to detail, will see you flourish in this interesting and rewarding role.
**Why QBiotics**
QBiotics is a growing company with strong ethics-based values and a culture of responsible corporate citizenship. We have an organisational structure which fosters collaboration and innovation and we actively support the professional growth of our people.
**How you Apply**
**Salary**: From $70,000.00 per year
Schedule:
- Monday to Friday
Work Authorisation:
- Australia (required)
Work Location: In person
Application Deadline: 13/07/2023
