Quality Manager

Recruiter
Clinical Professionals Ltd
Location
London (Greater)
Posted
31 Jan 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Quality Manager Location: Hertfordshire Salary: Dependent on experience, plus benefits Duration: Permanent Please note, you must be eligible to work in the UK. A specialist in Cell and Gene Therapy have an exciting opportunity to join them on a permanent basis as a Quality Manager. Reporting to the Vice President of Quality you will have responsibility of managing and performing the day to day activities, contributing to the on-going development of the companies quality management system, provide quality support to their UK manufacturing operations and support a team of specialist in manufacturing cell therapy products for clinical use. For the successful candidate this position offers exceptional long term incentives such as; QP training for IMP QP Certification if desired, as well as long term development and progression opportunities. Responsibilities (to include, but not limited to): * Perform routine QA duties to ensure manufacturing, testing and clinical trials activity comply with GMP, GCP, GCLP, HTA and other regulatory authority requirements relating to manufacture and clinical trials for AT(I)mp's and Cellular Therapies including; Change Controls, CAPAs, Deviations and OOS reporting, product complaint and recall handling, internal audits, vendor qualification including external audits as necessary and batch record review prior to QP release. * Develop and manage the UK QMS. * Set up and ensure the company's activities conform to the requirements of both Quality Management Systems managed by both the company and their client partner. * Advise the company's manufacturing and R&D teams on quality related issues. * Inform the VP of Quality and Senior Management of significant quality related matters or risks that could impact product quality, product release or regulatory compliance and work to resolve issues in a timely manner. * Co-ordinate the import, release by the QP and dispatch of clinical trial materials that are imported from the US and EMEA. * Organise training of UK site personnel and deliver basic GMP training. Experience required: Essential * 5 years working experience in a GMP environment or equivalent experience (in particular small scale clinical trials or manufacturing individualised patient products). * University degree in a biological science, pharmacy, chemistry or equivalent. * A good working knowledge of EU GMP. * A good working knowledge of Cleanrooms, aseptic techniques and hygienic requirements for sterile products. Experience required: Desirable * A working knowledge of regulatory requirements that specifically apply for the manufacture of ATMPs or Cell Therapy products. * Experience in monitoring the effectiveness of Quality Management Systems. * Experience of electronic Quality Management Systems. * Good understanding of GCP, GCLP, GDP and HTA requirements. * Experience of training staff. Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion. GXP, GMP, GCP, GCLP, GDP, Audit, Auditor, QA, Quality Assurance, Global, SOP, Audits, CAPA, Quality Management System, QMS, Home Counties, Quality Manager, Clinical Research, Clinical Trials, Good Clinical Practice, Good Manufacturing Practice, Cell Therapy, ATIMP, IMP, Investigational Medicinal Products, Trainee QP, Trainee IMP QP, IMP QP, IMP Qualified Person, Qualified Person,

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