1 to 25 of 135 GMP Jobs

Job summary The Good Manufacturing Practice (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 Good Manufacturing Practice 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 »

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 »

and contribute to maintaining and developing QMS related to IT. Key Responsibilities: Ensure ongoing compliance of GxP IT systems and processes. Support adherence to GMP/GDP and GCP regulations, including data integrity legislation. Act as System Owner/Administrator for GxP IT systems within QA. Lead Computer System Validation more »

the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP). The successful applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and … Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP). Deputise for Senior Quality Systems Engineer when required, to ensure progression of departmental commitments. We are looking for someone who has: Minimum A level … Directive MDD 93/42/EEC Knowledge of FDA QSR Part 820 Computer literate to include MS Word, Excel and MRP Knowledge of GMP and audits Ability to work with minimal supervision and use initiative. Good interpersonal skills and the ability to communicate well in English both written and more »

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 »

FACS, ddPCR, ELISA, DNA sequencing, qPCR/PCR, cell culture and cell-based assays. Knowledge of European and US Pharmacopeia methods and FDA, EMA, GMP, WHO and ICH regulatory requirements if preferred. Sound understanding and demonstrated application of statistical methods/tools would be advantageous. Skills And Abilities Excellent written more »

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 »

GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, 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 »

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 »

LIMS database experience Knowledge of sampling and laboratory processes and willingness to extend know-how on the field Experience in a pharmaceutical/medicinal GMP environment Azure and Power-BI familiarity Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. more »

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 »

Undertake other duties in relation to the position as the Company requires, including working additional hours as requested by the Systems Delivery Manager Ensure GMP is adhered to in all areas of work. Understand Company’s Health & Safety Policy and follow all company HSE procedures.Report all accidents or any unsafe 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 »

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 »

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 »

degree level or above in life sciences, chemistry or a related file with experience of working in a regulated laboratory environment (e.g. GLP or GMP) • Experience in using and troubleshooting ELISA analytical systems as well as the ability to develop and validate analytical methods using ELISA. • The ability to document 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 Good Manufacturing Practice (GMP … serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing 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 »

monitoring good manufacturing 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 »