Quality Assurance Associate
Orion Group
- Liverpool
- Temporary
- Full-time
- To work with other shift QA colleagues to ensure that batch specific documentation and data, including batch release packs and lot release protocols, are reviewed and compiled for QA Manager/QP release. Ensuring compliance with licensed and cGMP requirements, identification and resolution/escalation of issues that may impact batch release, and timely release of batches in order to meet strict supply demands. To ensure that other team objectives are achieved and to monitor this progress, suggest and support execution of required work, and suggest and implement improvements.
- To perform PTC /AE activities, as required, to ensure root cause investigations are completed in a timely manner and critical items are escalated to management.
- To have an active involvement in site quality systems, deviations, change controls, SOPs and self-inspections. Actively maintain and promote a cGMP compliant culture, ensuring the highest standards of Housekeeping and Safety are applied in the team, in accordance with current regulations and procedures. To be permanently inspection ready, ensuring that the review, storage and archive of cGMP documentation and batch specific records is up to date and at the required standards.
- To participate in improvement project teams, where required, driving quality decisions and providing advice and technical support, where required. Coordinate completion of any resulting activities. Demonstrate creative problem solving within cGMP constraints and align with best practice.
- To perform training required for own role and keep own training records up to date.
- To cross-train in activities which will allow contribution and support to activities in other QO departments, as required by the business.
- Graduate level in relevant discipline or suitable alternative or equivalent experience within industry.
- Experience of working in a cGMP environment.
- Experience of Quality Assurance systems, procedures and industry practices desirable.
- Knowledge of cGMP regulations and background in the Pharmaceutical industry.
- Proven time management skills for planning and schedule of work.
- Proven Communication skills both written and verbal.
- Ability to work as a member of a team, but flexible to work on their own.
- General experience of Quality Management Systems.
- Computer Literate.
- Fluency in English.
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.