Compliance Manager (Cell Processing and Storage)Are you an experienced Quality and Compliance Manager with experience in the Biotechnology or Pharmaceutical industry? Are you well versed...
Compliance Manager (Cell Processing and Storage)
Are you an experienced Quality and Compliance Manager with experience in the Biotechnology or Pharmaceutical industry? Are you well versed with ensuring compliance within a Cell based processing company for the processing and storage of human blood cells?
My client based in the Cambridge area is a highly successful Biotechnology company working within a number of areas on client specific projects. Working within the field of Cell based products, they work on the processing and storage of human cells in compliance with the Human Tissue Act.
They are currently seeking a Compliance Manager to ensure maintenance of the company Quality Management System and all related areas, in addition to maintaining compliance with the HTA.
The main responsibilities of the Compliance Manager role will be:
- Develop and maintain a Quality Management System to ensure compliance with legislative and regulatory compliance.
- Ensure compliance with use, storage and disposal of Human Tissues, Genetically Modified Organisms, and other materials.
- Oversee application and maintenance of the Human Tissue Act (HTA) licence.
- Development of plans for implementing ISO9000 compliance for Cell Line Development.
- Conduct internal audits to ensure legislation compliance; raising and implementing CAPA's.
- Member of the HTA Governance Committee
To be considered for the role of Compliance Manager (Cell Processing and Storage) you will have:
- Experience within the Biotechnology/Biopharmaceutical or CRO industry (E)
- Experience developing and maintaining a Quality Management System (QMS) (E)
- Strong experience in quality and compliance activity; auditing, CAPA's (E)
- Experience with cell based products or tissue processing (E)
- Some experience of the Human Tissue Act (D)
- Experience in a GMP environment (D)
If you have the background within Biological products and sound experience with maintaining a Quality Management System, please apply as this is an urgent requirement.
For more information please contact Keith Mulgrew on 01223 234768
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.