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Job Details

Senior QA Specialist - GMP

Company: ProClinical Ltd
Location: Hertford
Reference: QA.CR.15320
Closing Date: 21 Feb 18
Type: Permanent
Salary (£): Negotiable

Job Summary:

ProClinical is seeking a Senior QA Specialist for a major new initiative focused on cell therapy. 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. ...


ProClinical is seeking a Senior QA Specialist for a major new initiative focused on cell therapy. 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.

Job Responsibilities:

* 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.
* 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 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.
* 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.

Skills and Requirements:

* 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.
* Highly motivated, pragmatic and practical to support the mission of the company 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.
* Educated to Degree level in a life sciences discipline.
* Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable)

To Apply:

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 Courtney Russell on +44 203 8141 315 or upload your CV on our website -
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.

Apply for this job: Senior QA Specialist - GMP

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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