Hobson Prior are looking for an QA Specialist to join a leading pharmaceutical organisation on a permanent basis in Stevenage. Our client focuses on advancing the growth of cell and gene therapy research across the UK, helping to promote the use of these therapies throughout the health services all over the world.

Job Responsibilities:

• 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.
• Represent as a single point of contact for all Quality interactions between the Manufacturing Centre and a Collaborator.
• Partake in the preparation for and the management of regulatory agency and client inspections.
• You will ensure the QMS is maintained in a fit for purpose state of control for a multi-purpose, multi-client facility.
• Deliver 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.
• Partake 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.
• Partake 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.

Key Skills:

• You are highly motivated, pragmatic and practical.
• Capable of managing multiple and varied tasks and prioritize workload with attention to detail.
• Ability to evaluate complex situations and find solutions for them in a professional manner.

Requirements:

• Educated to Degree level in a life sciences discipline.
• Experience in sterile manufacturing processes, ideally ATMP's or biologics.
• 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.
• Having current and up to date professional knowledge, expertise and best practice.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.