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 »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review and approval of protocols, reports, methods, master more »
Maidenhead, England, United Kingdom Hybrid / WFH Options
SRG
well established Quality team, focusing on the supply chain. We are seeking a detail-oriented and experienced QA officer with a background in pharmaceuticals (GMP) and an understanding of Good Distribution Practice (GDP). The ideal candidate will ensure compliance with regulatory standards, optimize supply chain processes, and uphold company more »
Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective Global and Regional Quality Leads and functions · Ensure the establishment more »
Stevenage, England, United Kingdom Hybrid / WFH Options
Taleo BE
GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMPmanufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do more »
stakeholders. Strategic thinking and problem-solving abilities, with a proactive approach to regulatory challenges. Familiarity with quality management systems and regulatory compliance frameworks (e.g., GMP, GDP, GCP). Ability to thrive in a fast-paced, dynamic environment and effectively prioritize competing demands. more »
Cheshire, Chester, North West Hybrid / WFH Options
Real Staffing
providing direction and leadership to staff to ensure a quality mindset is embedded in the business Requirements: Expert in GCP with working knowledge of GMP 5 years experience in a QA Manager role within a CRO, Biotech or Pharma company Contract: Hours: 3 days a week - can worked across more »
required certifications): Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering; Min. 5 years of experience in quality operations in the GMP environment; Other languages are an asset; Knowledge and understanding of regulatory requirements; Good knowledge in office tools (e.g. Word, Excel, SAP). Additional Preferences: Working more »
a Qualified Person to join our team at Harlow, UK. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials more »
Manchester Area, United Kingdom Hybrid / WFH Options
Factorytalk
have requirements: 2-5 years’ experience working with MES/EBR or similar systems in the life sciences industries. Experience deploying MES in a GMP environment, configuring Recipes, MBR’s, Materials, BOMs, Order Management, Equipment management, Batch Review/Approval and other typical components. A background in one or more 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 »
be considered, to be clear we are looking for someone who has commercial lab experience working to QMS like UKAS 17025 or GLP/GMP/BRC) or GC/MS experience Strong interpersonal, organisation skills Able to work towards deadlines Good IT skills Important Information: We endeavour to process 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 »
Unit 69, Listerhills Science Park, Bradford, England
Cormica
skills Qualifications Maths, English and Science GCSE or equivalent, grade A* - C (9 - 4) (Desired) About the Employer Cormica Cormica Bradford Ltd is a GMP/GLP accredited specialist contract research laboratory (CRO), with over 25 years’ experience in delivering high quality analytical and laboratory support to the pharmaceutical, medical more »
clinical study teamsRequirements:• Extensive clinical operations experience gained in a biotechnology or pharmaceutical company• A relevant life sciences degree• In-depth knowledge of GCP, GMP and GLP requirements• Proven ability to lead the delivery of high-quality clinical studies• Leadership and program management experience• Ideally have experience in CNS or 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 »
QA Specialist Moreton, GB (Hybrid) 12 Month Contract – Likely Extensions/permanency £20 per hour Function PDQ GoodManufacturingPractice (GMP … serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with GoodManufacturing Practices (GMP) and other applicable regulations and internal procedures. Key responsibilities include drug substance and drug product batch disposition (release/reject decision), product certification and … release by the UK/EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections. Primary Responsibility: Review and label vendor specifications in accordance with relevant more »
Huntingdon, Cambridgeshire, East Anglia, United Kingdom
MM Flowers Ltd
monitoring goodmanufacturing practices, applying HACCP principles and preventing reoccurrence of non-conformance against these standards. To audit compliance against Quality Management Systems and GMP, raising all non-conformances against relevant standards with objective evidence enabling the operational teams to take the appropriate and necessary corrective action, to follow up more »
experience leading IT at a senior management level • Track record of delivering results quickly • Experience in delivering IT services to customers • Work in a GMP or highly regulated environment Preferred Experience: • Experience of agile product development • Experience of Lean Six Sigma • Infrastructure delivery (networking, hardware) to customers • Experience with data 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 »
and vision systems integrated within packaging equipment including interfaces with enterprise systems. Responsible for providing cGMP compliant control systems as per GAMP5 and EU GMP Annex 11. Key Experience Essential - Practical experience working within manufacturing and packaging environments Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning more »
with all company policies and procedures. Employee works in accordance with the installed ISO 9001 quality system and, if applicable, works in accordance with GMP-API. Your Profile BSc with previous working experience in a peptide lab is essential, MSc preferred Previous experience in a similar role would be desirable more »
knowledge of material design such as solid state science, material science, structural informatics, data sciences, and work experience from a regulated environment (GLP/GMP). A habit of driving continuous improvement and Lean culture. Cultural awareness. Desirable requirements Scientific leadership skills, the ability to deliver robust scientific contributions to more »
activities. What you'll need to succeed Our client is looking for an individual with strong experience as a Quality Assurance Officer within a GMP Pharmaceutical/Cleanroom environment. Other key desirables include: Quality Management System activities and maintenance. Experience in participating in internal/external audits. Be able to more »
PhD or relevant degree in any chemistry or life science related subject. The ideal candidate will have previous experience of working to GLP/GMP Must be IT literate with competent use of the Microsoft systems. The ideal candidate will have previous experience of using LC-MS/MS. Previous more »