Jason Johal is currently recruiting for a Quality Assurance Specialist to join a major initiative to grow a cell therapy industry delivering health and wealth for the UK. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapies and a place where collaborating businesses can start, and confidently grow. Based within their brand new state of the art manufacturing centre in Hertfordshire, this role is offered on a full time permanent basis and comes with a salary of £45,000 - £50,000 + benefits.
The Quality Assurance Specialist will support the development of a framework of Quality processes and systems that defines, directs and governs the tactical application of GMP compliance maintenance for the Manufacturing Centre. In the first instance this will be predominantly focused on supporting the delivery of a fit for purpose quality management system and practical quality subject matter expertise. This will involve participation in the process mapping and the development of associated procedures for controlling key quality and business processes in addition to helping develop the measures and governance structures to be employed to maintain visibility on the processes and interactions within and across them. They will also ensure that the Quality Management System established is maintained in a compliant manner suitable for both the new Manufacturing Centre and the interface with existing Company Operations. The role will involve supporting the centre validation activities and the development of the centre Quality Control service provision.
Reporting to and with the guidance of the Quality Assurance Lead, this role will ensure that the new Manufacturing Centre, via proactive engagement, meets the standards and expectations of two key stakeholders; the regulatory authorities and potential collaborators. Once operational, the role shall be responsible for the maintenance and continued development of the quality management system and monitoring compliance employing agreed key performance indicators.
Your main responsibilities in this role will be to:
• Work within a multi-disciplinary team to take a tactical role in the design, implementation and establishment of suitable governance processes to assure the consistent GMP compliance of the new GMP manufacturing facility for cell and gene therapy.
• Participate in the preparation for and the management of regulatory agency and client inspections during the build and validation phases plus operational phases of the centre
• Participate in the development and implementation of an electronic QMS to support; GMP documentation lifecycle management, change management (planned and unplanned), training compliance, CAPA, self-inspection, laboratory out of specification/out of trend incidents, regulatory inspection commitments etc.
• Maintain processes, including GMP document control and training, needed for successful site compliance to the QMS
• Participate in the execution of a GMP internal audit programme including the identification and implementation of appropriate corrective actions and a process to track their completion
In order to be considered for this role, you will be required to have the following skills and experience:
• Participation in the building of and establishing GMP quality systems.
• Previous exposure to R&D interfacing environment (Desirable).
• Experience in interacting with the regulatory authorities (Desirable).
• Experience in interacting with clients and collaborators (Desirable).
• Sound knowledge of EMA and FDA regulatory environments and requirements.
• Familiar with global standards related to quality e.g. ISO 9001.
• Experience working as a Quality Specialist or equivalent in biologics and preferably cellular and/or gene therapies.
• Track record of successful individual and team working.
• Educated to Degree level in a life sciences discipline (or equivalent)
• Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable)
If successful you will be joining a highly successful group with a core facility already established in central London and you will be instrumental in establishing this new facility and continuing change the future of the cell therapy industry.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Please quote ref ST39492.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 5th July 2017
- Expires: 2nd August 2017
- Reference: ST39492