Job Overview

Apply now We are now looking to recruit a QP / QA Manager to join our busy QA team. Reporting to the Board of Directors, the QP / QA Manager will act as one of the named Qualified Persons on the Manufacturing Licenses and will be responsible for all aspects of the Quality Management System within the company. This person will also act as Responsible Person (RP) on our license. This split role offers a chance for diversity and a new challenge. The role is full time Monday-Friday, 40 hrs per week. Responsibilities: Perform the duties and responsibilities of a 'Qualified Person' as detailed under the provisions of EU Directive 2001/83/EC (Human Medicines) and 2003/94/EC (cGMP). Ensure that Marketing Authorisation (Assembly Only) requirements have been met for all batches of medicinal products, prior to certifying and 'release for sale' of these batches to the market. Maintain and develop the Quality Management System to meet current regulatory requirements including but not limited to the SMF, QM, Quality Risk Management, Risk Assessment, Qualification / Validation Protocols & Reports, PQR, Deviation, Internal & External Audits, CAPA, Change Control, Training, Documentation. Ensure that principles and guidelines of cGMP (Directive 2003/94/EC) as interpreted in the EU Guide to cGMP and CGDP (The Orange Guide), have been followed. Be present and participate during the MHRA inspection, whenever it occurs. Act as Responsible Person as per requirements of the WDA(H) to ensure that the conditions of the licence are met and the guidelines of GDP are complied with. Other responsibilities Maintain strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs). Influence site compliance to Quality policy and Quality Management System procedures. Manage and supervise an adequate number of suitably qualified QA/QC personnel and to ensure that a continuing programme of training is carried out. Train QA/QC team members in order to maintain the highest stand of quality and excellence. Approve specifications, sampling instructions, test methods and QC procedures, including amendments. Review and evaluate all completed manufacturing and packaging documents to ensure that each batch has been produced, tested and packed in accordance with the directives and the marketing authorisation. Approve or reject starting materials, packaging components, intermediate bulk and finished products. Approve and monitor suppliers of raw materials and packaging components. Check and ensure that all equipment is qualified and maintained to the required standards. Investigate in accordance with written procedures all complaints relating to the quality of the products and if substantiated to initiate action to prevent recurrence. Liaise with regulatory department on all aspects of Product Change and deviations from specification and the validation required before changes can be implemented. Liaise with regulatory department for variations / new manufacturing authorisations or other regulatory submissions. Liaise with departmental managers in order to ensure that changes to the directives are incorporated into company policy and systems. Ensure that approval from the MHRA is obtained for all variations and amendments which alter either the Manufacturing or Product Licences. Liaise with the MHRA and the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licences. Coordinate the preparation and hosting of MHRA and customer inspections. Conduct timely internal quality audits in accordance with annual audit programme and compliance with the EU Guide, SOPs, etc. Refuse to sanction any action that might adversely affect the quality of any products on site and to keep the Directors informed of any problems relating to the quality of the Company's products. Disseminate the ethos and practice of quality to all Chemilines staff, by way of formal and informal training, offering advice, listening and communicating issues to senior management personnel. Skills & experience Qualified (EU) QP, 1 year batch release experience 1 year RP experience Previous min. 8 year experience within a Pharmaceutical Industry, GMP/GDP environment and Quality Assurance, and min. 5 years on managerial level Proven experience working in quality control/assurance, or regulatory assurance Proven experience in Quality Management Systems (QMS) and ensuring continuous improvement Experience with some or all of the following: Deviations/Investigations CAPA, complaints and recalls Risk management plan Experience in performing internal audits Experience working with pharmaceutical supply chain Experience in supplier/customer qualification, transport company qualification and transport validation Competencies Excellent communication skills - both written and oral Accurate and precise People management and influencing skills Analytical and problem-solving skills Exceptional conflict-resolution skills Ability to prioritize and drive multiple programs Qualification UK recognized Bachelor degree in Pharmacy/Chemistry/Biology/Bio-technology About us Chemilines Group is a successful importer, wholesaler and distributor of pharmaceuticals, generics and branded fragrances. We are also manufacturers of surgical dressings and medical devices. With a growing customer base and increasing product portfolio the Company is now set for further expansion. Providing excellent customer service support and production facilities, the company is dedicated to its customers who include leading retail and national pharmacy groups & wholesalers. We are located in Wembley, West London. The nearest Tube stations include, Alperton, Hanger Lane and Perivale (Piccadilly & Central Lines). What we offer A friendly and supportive work environment. F

Key Requirements

Quality Management MHRA People Management