Job summary The GoodManufacturingPractice (GMP) Unit at Guy's Hospital was formed to accelerate the translation of novel approaches to the prevention, diagnosis and therapy of major unmet diseases relevant to the NHS, and will ultimately contribute to the improvement of patient outcomes. Specialising in developing and manufacturing … cell and gene therapies for use in early phase clinical trials, the GMP Unit is looking to appoint a Advanced Therapy Quality Scientist. Main duties of the job The field of Advanced Therapy Medicinal Products is expanding rapidly; this post gives the prospective candidate the opportunity to expand their horizons … a Clean room. Desirable Experience in cellular immunology techniques such as proliferation, LDA, HLA-peptide multimers, cytokine secretion and ELISPOT assays Experience in GoodManufacturingPractice Skills Essential Ability to participate in the organisation of the laboratory Ability to develop novel QC assays and assess suitability Knowledge of: environmental monitoring more »
manufacturing operations. Are you a QA Manager that has experience Performing QA Duties to ensure manufacturing, testing and clinical trial activities that comply with GMP, GCP and other regulatory guidelines Document Control systems Change Controls CAPA - Corrective and Preventative actions Deviations & OOS reporting Compliant and recall handling Performing internal Audits more »
City of London, London, United Kingdom Hybrid / WFH Options
Connect With Ltd
promoted internally. We need someone who has experience working in a Pharma/life science environment who has good knowledge of working in a GMP/GxP environment. This is a strategic role and requires someone who has previous regional experience with some auditing experience. The role is based from more »
of Quality Assurance principles within the Pharmaceutical Industry. Strong understanding of Quality Management Systems in the pharmaceutical sector. Thorough familiarity with ICH-GCP and GMP guidelines. Experience in hosting Sponsor audits and/or Regulatory inspections. Demonstrated ability to organize and conduct internal and/or vendor audits. more »
record in Leading the HSE function across multiple companies in a Pharmaceutical environment. It is key that you have experience within a GXP/GMP environment. Purpose of the Job Health, Safety & Environment Lead and provide oversight and Global strategic leadership covering health, safety, and environment across the Pharmaceutical account. more »
in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience hosting, supporting and preparing MHRA inspections and auditing IT systems. Experience organising and performing internal and/or vendor audits. Experience working in more »
other DSP, Facebook, Twitter Experience of managing vendor relationships Regularly contributes to platform best practices and campaign processes Experience with Google stack and have GMP & Adwords certifications (desirable) Experience with running campaigns across multiple countries/languages Experience with managing a mid- to large-sized team across a range of more »
developing products used in hazardous environments (i.e. ATEX, nuclear or chemical industries) is preferred but not essential, as would experience of GoodManufacturing Practices (GMP) for the pharmaceutical industry, although neither are essential. Hybrid and flexible working can be discussed. More information available upon application. When applying for this role more »
development, licensure, and marketing of chemical drugs, biologics, or gene therapies. Liaise with U.S. and UK/Shanbally teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or renewals. Participate in cross-functional project teams as a regulatory CMC representative for project more »
Chain) Represent the business to external stakeholders as the MSAT technical expert Collaborate with R&D to ensure the early pipeline is compatible with GMPmanufacturing To be a successful candidate for the Senior MSAT Scientist role: Masters or PhD education (Life Sciences, Biochemistry, Biotechnology or similar) Previous experience in … GMP experience Cell Culture | Upstream | Specialist | MSAT | CMC | Cell Therapy | Technical Operations | Scientist| Downstream | Tech Transfer | MS&T | Technical Transfer | Process Development | GMP | goodmanufacturingpracticemore »
analytical team to contribute to the overall group objectives and development of staff. Ensure that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance's, and is undertaken in accordance with applicable procedures (e.g., SOP's, Protocols, etc). Requirements … Proven track record of managing a team within a cGMP QC analytical environment. Degree in a relevant scientific discipline or equivalent experience. Understanding of GMP requirements e.g. legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of … EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10. Apply now If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy more »
Job summary We are looking for a pharmacist/scientist to join our radiopharmacy team. The successful candidate will provide specialised GMP and quality assurance services within the Radiopharmacy manufacturing service for established and novel SPECT and PET radiopharmaceuticals. You must have advanced knowledge and experience working within an aseptic … provision and delivery of the Radiopharmacy service. To maintain the Pharmaceutical Quality System of the Radiopharmacy service which is a requirement of EU GoodManufacturingPractice and the Manufacturer's "Specials" Licence issued by the Medicinesand Healthcare products Regulatory Agency (MHRA). To act as an authorised releasing officer for … provision and delivery of the Radiopharmacy service. To maintain the Pharmaceutical Quality System of the Radiopharmacy service which is a requirement of EU GoodManufacturingPractice and the Manufacturers Specials Licence issued by the Medicines and Healthcare products Regulatory Agency (MHRA). To act as an authorised releasing officer for more »
qualifications and experience: 5 years experience in an environment associated with the manufacture, testing, and dispensing of radiotracers. Relevant experience of GoodManufacturingPractice (GMP), typically 2 years post qualification. Experience of working in Radiotracer production facility, Aseptic service or similar environment. Experience supervising technical staff and management of resources. more »
always opportunities to learn and gain exposure. Experience: Previous experience in a QA position within a pharmaceutical, healthcare or food setting Working experience of GMP Operational Quality Assurance experience including batch review/release Exposure to handling complaints processes Lifecycle experience of deviations, CAPAs and change controls Strong stakeholder management … Mark Bux-Ryan for further information quality, assurance, QA, QC, control, analytical, chromatography, HPLC, laboratory, documentation, analyst, officer, specialist, executive, administrator, good, manufacturing, practice, GMP, GLP, audit, SOP, training, complaints, batch, review, release, CAPA, deviation, change, control more »
with regulatory standards and fostering a culture of continuous improvement. Key Responsibilities: Manage all site-related QA operations in accordance with Quality Agreements and GMP guidelines. Serve as the QA representative on the Site Leadership Team. Lead adherence to local or corporate Quality Management Systems (QMS). Collaborate in developing … for site use. Conduct external audits as necessary. Provide strategic input into decisions impacting the Quality Assurance department. Deliver QA-related training and basic GMP training as needed. Act as a subject matter expert on Quality-related processes. Lead or represent QA in related projects, identifying metrics, issues, and mitigation … and develop a team of QA professionals. Support quality-related activities across sites as required. Minimum Qualifications and Experience: Minimum 10 years' experience in GMPmanufacturing, with a focus on QA/Quality roles. Experience in QA support for ATMP manufacture preferred. Demonstrated leadership of small QA teams. Proficient in more »
are under control Check compliance to Food Safety and Quality Management System procedures (QMS) including control measures for Allergens Conduct GoodManufacturingPractice audits (GMP) audits/Compliance Observation Process (COP) checklist Complaint investigation Check products against factory product specifications to ensure compliance with specifications, legality, and consistency in quality more »
they are met. • Oversees and performs complex ǪA activities involving evaluating and reviewing processes to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MPs including. • Identifies and communicates significant quality … and batch records prior to ǪP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met. • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique, and hygienic requirements for sterile products • Extensive knowledge of regulatory requirements or processes that specifically apply for the more »
London, England, United Kingdom Hybrid / WFH Options
i-Pharm Consulting
role will be joining the UK team, as a senior individual contributor and part of a global team. Other essential responsibilities include: Management of GMP and GDP compliance Management of complaints, CAPAs, risk assessments, and validation protocols Review and manage the QMS system Able to manage non-compliance issues and … requirement will be that you are able to travel to West London site and to supplier sites. It is a must that you have GMP and GDP experience. The role will be joining a team which is integral to the business and requires strong communication skills. The team are close more »
Chelsea and Westminster Hospital NHS Foundation Trust
standards including dispensing errors and other incidents. Maintains effective communication links with the Lead Pharmacist and Lead Technician to ensure practices reflect adherence to GMP and national requirements, Health and Safety legislation, COSHH and Trust Medicines Policy. About us About the Trust Chelsea and Westminster Hospital NHS Foundation Trust provide … sciences GPHC registered Staff management and skills(interviewing,apprasial etc) Evaluated service audit Significant experience in aseptic setting QMS experience Good communication Knowledege of GMP and principles of aseptic dispensing Word processing, email and data entry Organisational and prioritisation of workload Interpret and dispense prescriptions accurately Able to use initiative more »
with customers standards as well as the customers COP Internal Auditing management Non-conformances management Developing and maintaining a robust auditing program to include GMP, glass, wood and other physical audits Conducting daily QA checks, assessing raw materials specifications, management of technical runner Providing training for new starters Lead investigation … Main contact for pest control and chemical supplier To support the Head of Technical by ensuring site compliance to the quality manual and enforcing GMP practices in the manufacturing and warehouse units This is a hands-on position. Key Performance Indicators (KPIs) Maintain current level of BRC accreditation Second party more »
GMP Pensions Specialist (Split with other specialist area) London Reputable and well known consultancy seeking a GMP consultant to work in a split role across GMP and another specialist area of their choosing | National role which can be based completely remotely or from any of their UK offices. Company client … pleased to be working with a reputable and well known consultancy seeking a GMP consultant to work in a split role across GMP and another specialist area of their choosing (risk settlement, member options, pension scheme wind-up). You will work as part of a well established projects team … with a focus on delivering GMP Equalisation projects for clients. You will also be given the opportunity to work in a split role, spending half of your week in another specialist team of your choosing. This is a crucial role to the business in a booming area of the market 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 »