Skipton, North Yorkshire, Yorkshire, United Kingdom
Dechra
changes). This will require close collaboration with Product Development, Production and QA groups on NPIs using product lifecycle approach, preparation and approval of GMP documentations to support such projects, scheduling, raw material acquisition, supervising engineering batch manufacture, etc. Identifying potential process improvements for existing commercial products including proposals for more »
in place to meet legal and statutory requirements. Keep records and provide reports in accordance with good engineering practices to external audit standards. Upholding GMP engineering standards across site, statutory inspections are compliant, and any non-conformances are closed out with root cause analysis to avoid repeat failure. Lead the more »
biopharmaceutical company in the North of the UK. Looking for a CSV Engineer who has experience in: Testing analytical and lab support systems to GMP requirements. Working closely with IT & Laboratory departments to interface lab equipment with company network for secure storage of generated test data and backup of test more »
Technical QA Manager (m/f/d) - Quality Management/Qualification/Validation/CSV of Small Molecules/Data Integrity/GMP/IMP/English & German Project : For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Technical QA Manager (m … Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland. The candidate supports the end to end cGMP activities … in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics. Tasks & Responsibilities: * QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in Basel * Support of implementation of DI requirements * Review more »
Camelford, Cornwall, South West, United Kingdom Hybrid / WFH Options
Saputo Dairy UK
to demonstrate the ability to learn the technical aspects of processes. Able to show an understanding and willingness to comply with all food standards (GMP, health & safety etc.) consistent with working in a world class food manufacturing environment. WE SUPPORT AND CARE FOR OUR EMPLOYEES BY PROVIDING YOU WITH We more »
QA Manager (m/f/d) - GMP/Quality Risk Management/Qualification/Validation/Parentals/English & German Project: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified QA Manager (m/f/d). Background: The IMP Quality … the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality, Quality Systems and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland. The Clinical Supply Centre in Basel for Parenterals is … responsible for manufacturing Sterile Drug Products for clinical studies. In the course of the implementation of Volume 4 EU Guidelines for GMP Annex 1 (C 5938, 22-Aug-2022) (and PIC/S PE 009-16 GMP Guide, Annex 1), the candidate supports and drives end to end the full more »
of the highest standard. Main duties of the job To be responsible for supporting the delivery of the PMU Clinical Trials service within the GMP and GCP legislative framework. To provide expert input into all aspects of the Clinical Trial process from liaising with Sponsors, set up and manufacture of … of Clinical Trial medicines to ensure a safe and efficient service. To ensure that all IMP activities undertaken within the Production Unit comply with GMP/GDP/GCP, Health and Safety and COSHH legislation and that all work documentation and procedure manuals meet these regulations. To support senior staff … in the tasks they undertake. Clinical trials To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure GMP, GCP, full protocol, CTA, and IMPD compliance. To generate quality technical agreements, commercial and supply agreements in response to acceptance of a clinical trial, liaising more »
Global Category Specialist for Cleanroom and EI&C (w/m/d) - GMP/cold room/management/SAP/English,German, French Project : For our customer a big pharmaceutical company in Visp we are looking for a highly qualified Global Category Specialist for Cleanroom and EI&C. … semiconductors for clean rooms) * At least 2 years' experience doing tendering of complex and large E&IC, clean room or cold room packages in GMP environment for the relevant industry * At least 7 years of experience in plant construction as well as in the areas of purchasing, sales, contract management 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 »
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 »