a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide leadership to the Quality Teams … the business and provide support to sister company for regulatory inspections and conduct self-inspection program Oversee the Pharmaceutical Management System. Implement the current GMP regulations and industry best practices, where applicable Support and develop the QA team Support/lead manufacturing deviation or testing out-of-specification/out … of-trend investigations Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guideline Qualifications and Skills: Qualified Person (QP) Knowledge and experience in manufacturing and testing of oral dosage forms and topical products Experience in releasing medicinal products in a fast-paced environment Experience in more »
company or CRO Experience on CMC documentation for respiratory devices is important Experience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacture Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory Solid experience … with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines Updated knowledge of ICH GMP is required Excellent communication, presentation, and interpersonal skills. Self-driven and motivated team player Familiar with working in a virtual set-up Fluent in written and spoken English more »
Responsibilities: - Perform environmental monitoring of the aseptic manufacturing facility and ensure all testing aligns with the Environmental Monitoring programme. - Maintain QC facilities to meet GMP requirements and conduct necessary checks to support health authority visits. - Operate and maintain laboratory equipment, ensuring all equipment is calibrated and suitable for use. Requirements … Microbiology or equivalent relevant work experience in a regulated industry (i.e. pharmaceuticals, biologics, or medical devices). - Proficiency in Microsoft Office and knowledge of GMP/GLP regulations, FDA regulations, etc. - Strong problem-solving skills, analytical abilities, and a keen eye for aseptic behaviour. If you are interested in learning more »
Lab Analyst/Senior Lab Analyst Serving Society through Science, Tata Chemicals Europe (TCE) is one of Europes leading producers of sodium carbonate, salt and sodium bicarbonate and other products, from our plants in Cheshire, UK. British Salt has been more »
products reach every corner of the globe with precision and efficiency. Be the guardian of quality, ensuring every launch meets the gold standard of GMP and GDP regulations. Tackle challenges head-on, turning obstacles into opportunities for innovation and growth. Keep stakeholders in the loop with your expert communication skills … Business, Life Sciences, Engineering). Strong experience in the pharmaceutical realm, where you've honed your project management skills. A deep-seated understanding of GMP and GDP guidelines. A proven track record of launching products would be advantageous. Great communication skills, coupled with the ability to navigate complex challenges with more »
in industry? Or do you already have a background in an industrial chemistry lab but would like to develop your skills further in a GMP environment? SRG Synergy are currently working with a world-leading pharmaceutical organisation located in Ware with a vacancy for a QC Analyst – Level 1 Synergy … instruments, software packages and other analytical techniques (E.g. Empower 3). Is proficient in problem solving and may have expertise in troubleshooting analytical equipment. GMP experience would be desirable. more »
to manage/adjust timelines and priorities; escalate issues and concerns as they arise. Ensure all activities are delivered compliant to defined processes and GMP; concerns/risks are identified. Ensure appropriate and complete records arising through operational activities are maintained and TPCs in compliance with GMP and that meet … commitments meet agreed timelines and quality KPIs. Interim Packaging Project Coordinator - The Skills You'll Need to Succeed: Experience working in an R&D GMP environment. Experience working in an operational Packaging Labelling Distribution (PLD) role within Clinical Trial Supplies. Knowledge of Clinical Trial Supply CMOs and their capabilities Knowledge … of the pharmaceutical and clinical development processes and their relationship to the clinical supplies delivery processes; aware of clinical supply GMP requirements and standards. Lean Sigma training/experience Project Management training/experience Experience demonstrating organizational and planning skills coupled with strong written and oral communication skills Demonstrated capability more »
West Yorkshire, England, United Kingdom Hybrid / WFH Options
Langton Howarth
is a particular need for this role/location An understanding of the principles of Chemistry, Degree/HNC in Chemistry preferred Knowledge of GMP procedures and best practices Valid, clean UK driving license Ability to travel in the UK and willingness to attend training in EU or USA The … responsibilities of the Field Service Technician – Analytical Instruments: Duties include Fault diagnosis, repair, routine servicing, certification, and installation of equipment in accordance with GMP guidelines 80% of your time will be spent on pre-planned maintenance visits and circa 20% breakdown support which will enable you to manage your time more »
CY Partners are currently looking to recruit an Analytical Team Leader on behalf of a growing County Durham based Pharmaceutical CDMO on a permanent basis. As well as routine analysis on raw materials, intermediates and finished products, this quality department more »
build brighter futures for colleagues, clients and communities. The role will form part of the projects team with the current focus being around delivering GMP Equalisation projects on the proposition to clients, which can incorporate or lead onto being involved in de-risking projects for clients over time. This is … with internal teams to deliver a streamlined service to other lines of business. Directly involved with the management of more junior colleagues within the GMP Equalisation team, including supporting with performance reviews, training, and personal development plans. Develop skills to support on various consulting aspects of GMP projects and have … in Pensions, with a focus on Technical aspects and solid exposure to consultants and broader client support teams. Experience of technical calculations required for GMP Rectification and Equalisation projects. more »
Loughborough, England, United Kingdom Hybrid / WFH Options
ECS Resource Group
pharmaceutical environment/Medical Device industry required Technical experience within the Manufacturing functions of a pharmaceutical company. Technical knowledge of Pharmaceutical Packaging. Vendor Audits (GMP, Technical and EHS) Knowledge in Supply Chain Risk management, GMP, Quality System requirements, the ‘Orange Guide’, equivalent FDA regulations and systems, procedures, products and organisation. more »
responsibility will be to ensure that all materials are tested according to agreed specifications and procedures, in agreed time frames and in accordance to GMP and company guidelines. Other key responsibilities will include to: - Qualify, maintain and calibrate all laboratory equipment according to procedures. - Maintain all laboratory Quality Systems and … Assurance Performance Indicators. Your Background: You are required to have the following qualifications, skills and experience: - Knowledge of Quality Control, Quality Assurance, Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products. - Stability testing experience - Hands-on HPLC experience - Good technical and scientific judgement. - Diplomatic, self-motivating … professional with problem solving and decision-making capabilities. - Basic understanding of GMP Guidelines and Regulations. Apply: For more information, or to apply for this QC Analyst position please contact Hannah Oakley on 01246 457711 or email hoakley@ckgroup.co.uk. Please quote job reference 56706 in all correspondence. It is essential that more »
within the Centre for Cell, Gene & Tissue Therapeutics. The post holder will be responsible for establishing a process development team that will support a GMP-compliant lentiviral manufacturing process. They will design and implement novel intermediate scale lentiviral manufacturing techniques in suspension cell bioreactors. The post holder will also develop … new downstream purificiation and packaging systems for the delivery of GMP-compliant lentiviral vectors to the cell manufacturing teams in the CCGTT. The post requires exceptional attention to detail and the ability to work in a systematic manner whilst keeping detailed records and managing junior staff. Main duties of the more »
focus on compliance within a specific bakery, working with the teams to identify non-compliance and full engagement and support to ensure company processes. GMP and procedures are fully understood. Work with the bakeries to ensure compliance with relevant customer standards and codes of practice. Conduct physical factory audits (outside … safety and quality. Ensure that the Quality Management System internal audit schedule is completed, and all actions closed out in a timely manner. Ensure GMP & QA CCP audits are conducted to schedule and any non-conformances raised to bakery management. Verify that close out actions are robust and complete. Communicate more »
Glasgow, Lanarkshire, Scotland, United Kingdom Hybrid / WFH Options
Ernest Gordon Recruitment
Private Healthcare + Free Parking + Life Insurance + Pension + Ongoing Training + Progression Are you a Laboratory Manager with a background in GMP looking to join a company that is passionate about revolutionizing cancer therapy? You will take on a leadership role where you will receive full product … Your duties will encompass supervising production operations, resolving issues in cell culture processes, and spearheading quality investigations. Your meticulous oversight will ensure adherence to GMP standards and facilitate the seamless integration of novel procedures. This role would suit a Laboratory Manager with a background in GMP looking to join a … role where you will receive full product training, tremendous growth opportunities all while working hybrid. The Role: Manage T cell-based therapy production, maintaining GMP compliance. Lead production, troubleshoot processes, and conduct quality investigations. The Person: Life Sciences or related field background. Regulatory knowledge of T cell Therapy. Demonstrated leadership more »
proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products andstability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data. Perform stability study programme activities, storage of in process … timely manner of any failure of calibration Maintain Quality Control information systems Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst Assist in investigation of quality incidents and other problem solving forums and … and conferences where appropriate Carry out general maintenance and house keeping of equipment and laboratories Essential Experience Experience within a QC laboratory working to GMP within a recognised quality system. Ability to organise work within a busy laboratory with experience of writing and working to SOP documentation. Knowledge of GMPmore »
and collaboration with Operations and Quality teams. Major Responsibilities Under the QC Manager's direction, the Incoming QC Team Leader will: Ensure GDP/GMP compliance within Incoming Inspection and Quarantine areas through inspection of incoming goods against specifications. Create and maintain incoming inspection procedures and work instructions. Manage QC … external audits (e.g., BSI, FDA). Support and complete other tasks set by the QC Manager. Skills and Experience Working knowledge of GDP/GMP requirements. Ability to create and write Standard Operating Procedures and Work Instructions/Specifications. Understanding of inspection criteria and the use of drawings/specifications. … area for medical devices. Knowledge of SAP (desirable). Knowledge of Master Control (desirable). Strong written and oral communication skills. Good understanding of GMP compliance requirements in Quality Control. Attention to detail. Promotes a collaborative working environment. Understanding of using basic measurement tools (e.g., calipers/jigs and gauges more »
role for you! As a Technical & Quality Coordinator, you will be: Updating and developing technical documentation. Ensuring the organisation remains compliant with food safety, GMP, quality, ACCP , and health and safety procedures . Conducting, and supporting with, internal and external audits and finished product traces . Recording all findings and … in food science or related field. Previous experience in a Quality & Technical role within food manufacturing . A strong understanding of HACCP, BRCGS, and GMP standards and food legislation . Computer literate with MS Office. Able to work well independently and part of a team. If you believe you meet more »
its capabilities. This will include ensuring activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed, in accordance with GMP requirements Responsibilities : Manage a team and ensure validation master plans (VMPs), protocols and procedures are established To prepare and maintain validation plans (VPs) and identifying … protocols for equipment, facilities and utilities Your Background: Degree (or equivalent) in a Science or related discipline Qualifications related to validation and quality compliance (GMP/ICH/FDA/USP/EP policies). Experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation more »
a leading Nuclear Medicine company based in the London area. As the Radiopharmacy Technician you will be responsible for manufacturing of PET Radiopharmaceuticals to GMP standards. KEY DUTIES AND RESPONSIBILITIES: Your duties as the Radiopharmacy Technician will be varied however the key duties and responsibilities are as follows: 1. Manufacture … working knowledge and practical experience with aseptic dispensing experience or working with isolators is desirable Key Words: Radiopharmacy, Radiochemistry, London, Chemistry, Technician, Radio Technician, GMP, Neclear medicine Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome more »
The Role - Development/GC MS/HPLC Scientist The Salary - Competitive The Location - Yorkshire Russell Taylor group has a brand-new opportunity for a chromatography scientist. If you think this role would be of interest, apply now to avoid more »
Summary: The Head of Quality Assurance leads strategic QA efforts, ensuring compliance and driving improvement. They oversee operations, manage teams, and maintain high standards. Responsibilities: Define and drive QA strategy. Set and monitor quality standards. Ensure compliance with regulations. Lead more »
Practice Leader - Head of GMP London Company client partnered with a leading pensions consultancy in the UK, who have seen continuous growth in 2024 and looking to continue with ambitious objectives. This consultancy is seeking a Practice Lead as Head of GMP. This role provides opportunity to lead the Actuarial … GMP team, leading a team of actuaries towards innovative solutions in GMP reconciliation, equalisation, and rectification for UK Defined Benefit Pension Schemes clients. Key Responsibilities: * Leading a mid-sized team, with numerous direct reports- supporting on projects covering GMP. * Provide high quality Actuarial and pensions expertise to clients * To contribute more »
any trends •Support Technical department and site with document creation and review which may include records, procedures, and communication boards •Complete audits on bakery GMP standards & Technical compliance such as G&HP, CCP, Process controls, Mobile phone audits, paperwork completion etc •Lead for Site Traceability exercise •Promote and maintain high … standards of food safety culture, promote and challenge site GMP standards including Technical, Food Safety, Quality, Compliance and Business values.. •To verify accuracy of handheld temperature probes, temperature-controlled storage equipment Qualifications&Requirements - Quality Systems & Compliance Assistant •Good IT skills with knowledge of Microsoft Office •Level 3 Food Safety •Internal more »
