QA Associate – £21ph
Currently recruiting for a Shift QA Associate to provide first line QA support to the Liverpool site on a 4 on 4 off day shift rotation.
This person will be responsible for providing cGMP and quality review, approval and decision-making to manufacturing and support functions. The role holder must be confident in making first line quality decisions. They will also work as a member of cross-functional teams and will support batch release activities as defined by the Quality Assurance Manager.
This is a temporary role until the end of the year with the view to being extended and an immediate start. A 4 on 4 off shift rota will be worked (7am start 12 hour shift).
- Ensure all manufacturing batch records are reviewed and compliant with the licensed and cGMP requirements.
- Ensure that other team objectives are achieved and to monitor this progress, suggest and support execution of the work plan, suggest and implement improvements to it.
- Provide support for deviation investigations, ensuring effective root cause investigations are performed and product quality implications accurately assessed. Identify repeat deviations and ensure appropriate corrective actions are taken. Ensure that minor deviations and CAPA, technical reports and other applicable documents are approved within the designated timelines.
- Review and approve technical protocols, reports, SOPs and other applicable documentation as specified in SOPs.
- Provide Quality Oversight for manufacturing and support functions ensuring that appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team and site areas of responsibility, in accordance with current regulations and procedures. Deliver continuous improvement of quality related metrics across all manufacturing and support departments.
- Perform SAP updates, self-inspections and area tours regularly as specified in the SOP, including regular internal audits.
- 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.
- Participate in coaching and feedback of trainee colleagues as applicable. To manage organisational change and process improvements as applicable.
- Graduate or able to demonstrate capabilities to this level
- Have a good knowledge of cGMP requirements and applicable process knowledge
- Experience working in a pharmaceutical environment
- Understanding of EU and FDA regulatory requirements
- General experience of Quality Management Systems
- Competent IT skills, particularly MS Excel and Word
- Possess good communication skills
- Ability to work as a member of a team, but flexible to work on their own
- Ability to manage multiple sets of information, prioritizing when required