A growing global leader in the development, delivery, and commercialisation of cell therapies have a fantastic job opening for a QA Specialist with their office in Stevenage. This is a dynamic and innovative organisation who pride themselves on their passion and expertise in the medical field.
- Taking 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.
- Acting as the single point of contact for all Quality interactions between the Manufacturing Centre and a Collaborator.
- Participating in the preparation for and the management of regulatory agency and client inspections.
- Ensuring the QMS is maintained in a fit for purpose state of control for a multi-purpose, multi-client facility.
- Providing general quality subject matter expertise for the facility operations.
- Providing compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes.
- Participating in the development and implementation of an electronic QMS
- Promoting the awareness of quality requirements and supporting the evolution of the quality culture throughout the company and train staff in quality related activities where appropriate.
- Maintaining processes, including GMP document control and training, needed for successful site compliance to the QMS.
- Participating in reviewing the performance of the QMS at planned intervals, providing regular reporting to ensure its continuing suitability, adequacy, and effectiveness, and proposing improvements.
- Participating 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.
Skills and Requirements:
- Educated to Degree level in a life sciences discipline.
- Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable).
- Experience in the building of and establishing GMP quality systems.
- Experience in sterile manufacturing processes, ideally ATMPs or biologics.
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josuha Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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