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 »
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 »
week. There will be an on-call rota. Key experience: Previous experience in a hands on engineering position within a regulated industry Experience of GMP is desirable but other regulated standards will be suitable Multi-skilled engineering capability – both mechanical and electrical An appreciation of IT and cloud based systems … a flexible approach to work For further information, please contact Mark Bux-Ryan. Engineering, manager, maintenance, electrical, mechanical, electro, mechatronics, planned, reactive, systems, controls, GMP, regulated, pharmaceutical, manufacturing, ISO, aerospace, food, chemical, quality, standards more »
the production of sterile injectable products, for the treatment of the flu. This is a fantastic opportunity for a Biological Science graduate with some GMP experience to further their career. Main responsibilities: Performing a range of immunological tests within a highly regulated Quality Control laboratory to GMP regulations. Performing routine … QC testing including ELISAs, and other assay work. Documenting laboratory results in an accurate and timely manner. Complying with GMP regulatory requirements at all times. Key requirements: Educated to BSc/MSc level in a relevant scientific subject (Virology, Immunology, Biological Sciences) Demonstrable experience performing ELISAs, PCR or other immunological … assay within a laboratory environment. Experience of working to GMP/pharmaceutical regulatory requirements is desirable more »
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 »
site and related functions are in compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have ownership for key quality system elements and will support and execute site quality more »
site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have support key quality system elements and compliance improvements, working closely with relevant stakeholders more »
+ 8 Bank Holiday Cycle to Work Scheme Skills and Qualifications Required for Analyst BSc or higher in Chemistry or related field Experience within GMP environment Physical characterisation including; particle sizing (image and laser diffraction), specific surface area, XRD, thermal analysis, water content Chemical ID analysis including; UV-vis, FTIR more »
for scaling up and down of bioprocess operations. - Understanding of how to develop and optimise processes for the purification of biopharmaceutical products. - Understanding of GMP and QbD considerations in a large scale manufacturing environment. - Understanding and experience with statistical and modelling software and tools. - Understanding of in-process assays such more »
team members on best practices and ensure compliance with regulatory standards. Conduct gap analysis, review change controls, and develop revalidation strategies as needed. Ensure GMP, Data Integrity, and GDP compliance, including timely training. Key Competencies: Proven track record in delivering regulatory-compliant validation strategies. Strong understanding of GxP compliance requirements. more »
in using industry-standard software lifecycle management tools such as Jira, Confluence, and AHA! Previous exposure to applying industry compliance and quality standards (GLP, GMP, 21CFRPart11) in software products. Effective communication and stakeholder management skills to facilitate seamless collaboration and alignment across diverse stakeholders. If you possess a passion for more »
the team's size and operational scope. Key qualifications: Extensive experience in Quality Assurance across diverse responsibilities Preferably, a background in pharmaceuticals, though other GMP environments will be considered Bachelor's degree or equivalent in a relevant technical field Strong proficiency across various quality functions such as batch review, investigations … into a senior leadership role within a fast-paced pharmaceutical environment, apply now to become part of a dedicated team. Keywords: Quality, QA, assurance, GMP, manufacturing, distribution, packaging, CDMO, pharmaceutical, batch release, systems, compliance, regulatory, specialist, investigations, CAPA, deviation, change control, operations, senior, leader, supervisor, manager, coach, mentor. more »
and on occasions as required If you would like to discuss this further, please contact Mark Bux-Ryan for further information. QP, qualified, person, GMP, manufacturing, sterile, terminally, sterility, aseptic, quality, assurance, manager, leader, MHRA, audit, release more »
and on occasions as required If you would like to discuss this further, please contact Mark Bux-Ryan for further information. QP, qualified, person, GMP, manufacturing, sterile, terminally, sterility, aseptic, quality, assurance, manager, leader, MHRA, audit, release more »
co-ordinate the day to day workload, ensuring items are manufactured in a timely manner and colleagues are supported. To follow goodmanufacturingpractice (GMP) at all times. To generate worksheets and labels, ensuring medicines are charged correctly using the pharmacy computer system. To in process check worksheets and labels more »
of pharmacist as required3.Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of Good Clinical Practice (GCP), GoodManufacturingPractice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management.4.To participate in the Trust-wide Out of Hours Medicines Advice Service and seven-day medicine supply more »
Oversee multiple QA projects, ensuring timely and effective execution. Compliance and Quality Assurance: Ensure all operations comply with regulatory standards (MHRA, FDA, etc.) and GMP guidelines. Risk Management: Identify and mitigate risks associated with aseptic processing. Continuous Improvement: Drive initiatives to enhance product quality and operational efficiency. Requirements: Experience: Minimum … and developing a team. Project Management: Strong project management skills, with the ability to handle multiple projects simultaneously. Technical Knowledge: In-depth understanding of GMP, aseptic processing, and regulatory requirements. Communication: Excellent interpersonal and communication skills, with the ability to influence and collaborate across all levels of the organization. Problem more »
naturally a flexible mindset is needed for this type of position. As such, I am interested in speaking with people from Production and QC GMP settings, as well as fresh graduates looking to get that key break. This team is very open to your background – it is all about your … experience would be advantageous but is not essential Experience and/or understanding of chromatography techniques including HPLC and GC. A solid understanding of GMP principles – or at least the ability to work to strict regulated procedures Flexible to work shifts Must have own transport to access the site due … to shift work QC, quality, control, analyst, analytical, laboratory, radiopharmaceutical, GMP, entry, graduate, science, pharmaceutical, biotechnology, manufacturing, shift more »
naturally a flexible mindset is needed for this type of position. As such, I am interested in speaking with people from Production and QC GMP settings, as well as fresh graduates looking to get that key break. This team is very open to your background – it is all about your … experience would be advantageous but is not essential Experience and/or understanding of chromatography techniques including HPLC and GC. A solid understanding of GMP principles – or at least the ability to work to strict regulated procedures Flexible to work shifts Must have own transport to access the site due … to shift work QC, quality, control, analyst, analytical, laboratory, radiopharmaceutical, GMP, entry, graduate, science, pharmaceutical, biotechnology, manufacturing, shift 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 »
Proclinical is seeking a dedicated individual for a Director of Quality Assurance position. This role is integral to our mission of developing solutions for some of the most crucial scientific challenges of our age. The successful candidate will be a more »
Job summary The Vaccine Development and Evaluation Centre department, based at UKHSA Porton, is the UK's largest capability for the handling of dangerous human pathogens and animal modelling of infectious diseases. The capability is used to understand pathogenesis and 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 »
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 »
