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The role holder provides cGMP and quality approval to manufacturing and support departments. The role holder must apply critical thinking to make first line quality decisions and be able to determine when escalation is required. You will also work as a member of teams and will support batch release activities as defined by the Quality Assurance Manager.
What you'll do
1. Batch Record Review
- To work with other shift QA colleagues to ensure that all manufacturing batch records are reviewed in the specified timelines to assure compliance with the licenced and cGMP requirements.
- To provide quality advice and coaching within the environment on the shop floor where manufacturing issues and questions arise.
- To ensure that other team goals are achieved and to monitor this progress, support execution of the work plan, suggest and implement improvements to it.
- To perform SAP updates in preparation for batch release.
2. Deviation/CAPA and Quality System Support.
- To provide support for deviation investigations, ensuring cause investigations are performed and product quality possible effects assessed. Identify repeat deviations and ensure appropriate corrective actions are taken. To ensure that minor deviations and CAPA, technical reports and other applicable documents are approved within the designated timelines..
- To review technical protocols, reports, SOPs and other applicable documentation as specified in SOPs.
3. To promote a Safety, Quality and cGMP culture in the team and across the site.
- To provide Quality Oversight for manufacturing and support departments ensuring that appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team and site responsibilities, observing current regulations and procedures. To deliver continuous improvement of quality related metrics across all manufacturing and support departments.
- To perform self-inspections and area tours as specified in the SOP, including regular internal audits.
- To be permanently inspection ready and prepared to participate as applicable.
4. To participate in improvement project teams where required driving quality decisions and provide advice and technical support where required. Coordinate completion of any resulting activities. Demonstrate creative problem solving within cGMP constraints and align with best practice.
5. To perform training required for own role and keep own training records up to date.
- To participate in feedback of trainee colleagues as applicable. To manage organisational change and process improvements as applicable.
Education Requirements
- Graduate in a suitable scientific/engineering degree
- Have a knowledge of cGMP requirements and applicable process knowledge
- Experience Requirements
- Minimum 1 year experience working in a pharmaceutical environment, preferably in a Quality related role.
- Experience of Quality Management Systems, having been involved with pharmaceutical DRs/CAPAs and Change Controls.
- Competent IT skills, MS Excel and Word.
- Have demonstrated through experience in management escalation, problem solving and technical writing.
- Work as a member of a team, but also make quality related decisions with minimal supervision.
- Knowledge/awareness of EU and FDA regulatory requirements would be beneficial
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.
