Are you a Quality Assurance professional looking for your next role in industry? We are currently looking for a Quality Assurance Officer to join a growing innovative life sciences company based in the Edinburgh area. As the Quality Assurance Officer you will be responsible for supporting the busy Quality department in operation of the Quality Management System through ensuring compliance with GMP, ISO9001 and Human Tissue Act legislations for the manufacture of stem cells and other cell therapies for life saving clinical trials.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Assurance Officer will be varied however the key duties and responsibilities are as follows:
1. Reviewing and approving Incident Reports, Change Controls, Risk Assessments and SOPs to ensure compliance with GMP and other relevant regulatory requirements.
2. Supporting management of the company's Q-Pulse documentation system. Performing data review audits, including of Batch Production Records, Validation Documents and Development Documentation, in addition to supporting Validation activities.
3. Performing internal audits to determine compliance with GMP and to identify areas for improvement. Additionally, review and approve suppliers/service providers to ensure efficiency and effectiveness. As the Quality Assurance Officer, you will also support the QA Manager with hosting customer audits.
4. Provide Quality advice and guidance to the team, with support from the QA Manager. Similarly, providing excellent customer service skills for both internal and external customers.
To be successful in your application to this exciting opportunity as the Quality Assurance Officer we are looking to identify the following on your profile and past history:
1. Minimum BSc degree in a relevant life science subject.
2. Proven industry experience in a GMP Quality department, and with Grade A/B GMP clean rooms.
3. A working knowledge and practical experience with cell therapies or cell biology and using the Q-Pulse Document Management or similar system.
Key Words: cell therapy | stem cell | clinical trial | quality | QA | GMP | good manufacturing practice | ISO9001 | human tissue | cell biology | clean room | Q-Pulse
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Jessica McLachlan
- Phone: 0203 910 2980
- Reference: J5632327
- Posted: 9th October 2019
- Expires: 6th November 2019