Quality Q-Pulse Specialist
Bath ASU (part of the Pharmaxo Group) produces over 2,000 aseptically compounded injectable pharmaceutical products each day to hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need pain relief. Through our scientific and technology capabilities, the team continuously develops new and innovative methods to improve our products and services.
As Quality Q-Pulse Specialist you will be a key member of the Quality Assurance team and will be responsible for the design, configuration, qualification, (re)validation, implementation, management and development of the ePQS. You will ensure that the ePQS is comprehensive and compliant with MHRA GMDP standards and ICH Q10.
You will drive continual development and improvement of the ePQS and you will manage and deliver training related to the ePQS.
Your Duties & responsibilities
- As Quality Q-Pulse Specialist you will have the skills and ability to train and provide mentorship on the ePQS and to promote the application of quality management.
- Ensure that there is a robust governance infrastructure over the ePQS, including configuration, access permission, audit trails and secure access. You will ensure that robust data integrity is maintained in accordance with all related regulations.
- Ensure that the ePQS is fully qualified and remains in a validated state when in operation. Any change to software or application must be subject to revalidation through the change control system.
- Ensure that all related ePQS SOPs are raised, approved, controlled and maintained.
- Ensure that there is a mechanism in place to ensure that all staff receive appropriate training (induction, refresher and update) and have access to the ePQS.
- To provide reports and trend analysis on the effectiveness of the ePQS at regular scheduled quality meetings.
- To review the ePQS to ensure that it matches the needs and requirements of all users, and that any changes are promoted for awareness.
- Act as the QA lead presenting the ePQS to an auditor
- Undertake any additional tasks and projects as required by the Head of Quality/QA Manager
- Undertake and record continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
- Support the development of activities and policies aimed at improving the effectiveness and efficiency of the service and improvement of the quality management system.
- To support the training and development of Production and QA staff.
- Other duties as required by the Head of Quality/ QA Manager
The skills & attributes you will bring
- Dynamic, self-motivated, proactive approach to taking on challenging assignment
- Creative and analytical thinking
- Excellent planning capability and be able to envision short term milestones which the company must achieve to succeed in the long term
This job description is not intended to be exhaustive. The post holder will be required to be flexible and take on projects and responsibilities as the company grows.
In return we offer rewards and benefits including:
- Competitive salary
- 29 days holiday inclusive of bank holiday (increasing with service)
- Generous Pension scheme
- Life Assurance
- Quarterly Company bonus scheme
- Additional non-contractual benefits including free breakfast and outdoor gym
By clicking ‘apply’ you will be taken to our careers page to complete your application.