Proclinical is currently recruiting for a QA Specialist for a pharmaceutical company located in Stevenage, England. Successful candidate will be responsible for developing and maintaining the Quality Management System at the Manufacturing Centre.
- 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.
- Act as a single point of contact for all Quality interactions between the Manufacturing Centre and a Collaborator.
- Participate in the preparation for and the management of regulatory agency and client inspections
- Ensure the QMS is maintained in a fit for purpose state of control for a multi-purpose, multi-client facility.
- Provide general quality subject matter expertise for the facility operations.
- Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes.
- Participate in the development and implementation of an electronic QMS
- Promote the awareness of quality requirements and support the evolution of the quality culture throughout the company and train staff in quality related activities where appropriate.
- Maintain processes, including GMP document control and training, needed for successful site compliance to the QMS.
- Participate in the review the performance of the QMS at planned intervals and provide regular reporting to ensure its continuing suitability, adequacy and effectiveness and propose improvements.
- Participate in the execution of a GMP internal audit program 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 organization e.g. RSC, SOB, CQI etc. (Desirable)
- Highly motivated, pragmatic and practical to support the mission of the Cell Therapy Catapult to accelerate the development of a commercial cell-based therapy industry in the UK.
- Able to evaluate complex situations and find solutions for them in a professional manner.
- Project ownership and pride in its delivery.
- Having a passion for delivering excellent customer service.
- Flexibility towards work assignments and new learning.
- Participation in the building of and establishing GMP quality systems.
- Experience in sterile manufacturing processes, ideally ATMP's 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.
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 call Alexander Coltman at (+44) 0207 854 5472 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical 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.