An exciting opportunity has arisen for an experienced Qualified Person to join a state of the art, dynamic and growing Biologics facility. This permanent role will give you exposure to both clinical and commercial products as the site will be building out their capabilities over the coming years.
This role will be a key cog in the QP team and will work extremely close with Operations. This is a tenured role so requires the individual to have at least 4 years' experience certifying batches for release and named on a licence. If you have done a large amount of batch release during this time, they may consider 3+ years' experience in this area.
A bit more about the role:
- Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to GMP and Company Procedures.
- Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorisation (MA) or clinical trial authorisation, product specification file, legal obligations and/or technical agreement. Manage and/or escalate any potential cGMP and/or other concerns in a timely manner.
- Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material.
- Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed.
- Provide oversight ensuring all manufacturing, testing, and shipping processes remain in the validated state.
- Review and approve the Annual Product Review for the drug substance and ensure that all variations, deviations, change controls and CAPA's are included for the period under review.
- Support supplier/material qualification and quality agreements review and approval as required.
- Support customer and supplier complaint process as required.
- Support Quality Risk Management processes as required.
- Support Market Action Response Team as appropriate in batch / product recalls.
- Ensure and promote compliance to regulatory requirements, evaluating site compliance against emerging regulatory trends and proactively engaging with global regulatory agencies when required.
- Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.
Qualifications and Skills:
In order to excel in this role, you will have:
- BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
- EU QP Qualification and experience (at least 4 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
- Proven track record in delivering operational excellence.
- Communication, decision making, people influencing and project management skills.
- Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognise potential compliance issues.
- Experience in biologics or chemistry based products is required with specific experience in audit readiness, regulatory agency engagement and ability to gain alignment on strategy with senior leadership.
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
