Posted: 06/09/2019 12:21
Level: Manufacturing Centre
Deadline: 29/11/2019 17:00
Job Type: Permanent
Purpose of Role:
The Quality Assurance Specialist will be responsible for developing and maintaining the Quality Management System at the Manufacturing Centre. 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.
The Quality Assurance Specialist will also be responsible for managing the Quality interactions between Manufacturing Centre Collaborators and the Cell and Gene Therapy Catapult and will be the primary Quality point of contact for a defined Collaborator.
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.
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.
To 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 programme including the identification and implementation of appropriate corrective actions and a process to track their completion.
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.
Knowledge / Skills / Competencies:
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.
Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
Comfortable operating autonomously once goals and objectives are set.
Excellent interpersonal, written and verbal communication skills.
Confidence and ambition to provide pragmatic and considered GMP advice.
Having current and up to date professional knowledge, expertise and best practice.
Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.
Ability to quickly establish credibility and build rapport and trust.
A good team player, with strong organisational skills.
Education / Qualifications:
Educated to Degree level in a life sciences discipline.
Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable)