J5631171MidlothianBiotechnology CRO/CMO Science PermanentCompetitiveFull Time20/03/2019Cellular Biology & Molecular Biology Cell Culture Quality Assurance Quality Assurance – Auditing Quality Assurance – Compliance Quality Assurance – GMP Production Production - Quality Control
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Do you have experience working under and implementing GMP quality systems?
We are currently looking for a Compliance Officer (GMP) to join an exciting cell therapy manufacturing company based in the Edinburgh area. As the Compliance Officer (GMP) you will be responsible for ensuring all compliance documentation is effectively completed and provide and liaison between the manufacturing and quality assurance departments.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Compliance Officer (GMP) will be varied however the key duties and responsibilities are as follows:
1. You will write, progress and coordinate the completion of manufacturing incident reports and support root cause analysis investigations. You will also draft and review change controls, and support change control activities including post-implementation reviews.
2. You will write and review SOPs, and review Validation documentation and witness key validation activities.
3. You will assist in the preparation for client and regulatory audits, and coordinate preparation of response documents for internal audits. You will carry out departmental quality checks with guidance from QA, and carry out quality improvement reviews and projects.
4. You will monitor all manufacturing activities to ensure compliance against SOPs. You will also ensure all Quality Management System KPIs are met through the review and coordination of document completion within the manufacturing team.
To be successful in your application to this exciting opportunity as the Compliance Officer (GMP) we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences subject, or equivalent training and experience
2. Proven industry experience in a biologics or cell therapy setting, with experience of sterile GMP manufacturing in a clean room environment.
3. A working knowledge and practical experience with Quality Management Software such as Q-Pulse. You will also have a sound working knowledge of GMP, and the ability to lead others to maintain and uphold GMP standards.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.