of QA activities for your assigned portfolio of projects. Your role will involve providing advice to support the development, implementation and continuous improvement of GMP quality systems across the development functions and support implementation of agreed global standards. You will interpret, trend and report compliance data, to measure and improve … Quality Assurance input to business improvement projects. Essential Skills/Experience: - Appropriate scientific degree with significant years of experience of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation - A broad understanding of Quality Systems and GMP is essential - An understanding of the pharmaceutical/drug development more »
its capabilities. This will include ensuring activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed, in accordance with GMP requirements Responsibilities : Manage a team and ensure validation master plans (VMPs), protocols and procedures are established To prepare and maintain validation plans (VPs) and identifying … protocols for equipment, facilities and utilities Your Background: Degree (or equivalent) in a Science or related discipline Qualifications related to validation and quality compliance (GMP/ICH/FDA/USP/EP policies). Experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation more »
be to: Perform physical and analytical testing of raw materials, intermediates and finished product using techniques including HPLC and GC. Ensure departmental adherence to GMP requirements. Verification and approval of testing data generated within the Q.C Laboratory. Ensure that laboratory housekeeping standards are maintained at all times and documented accurately. … Training of QC staff. To be considered for the position you should be an experienced QC professional with experience of people management within a GMP environment. Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence more »
to provide high quality, synthetic DNA for use in gene therapy and gene editing platforms. The company is growing rapidly and is establishing a GMP gene synthesis hub at its site just north of Cambridge, UK to facilitate the scaling and optimisation of a proprietary DNA manufacturing process. As a … essential. Experience of working in cleanrooms and/or manufacturing environments is desirable. An understanding of Quality Control or concepts of GoodManufacturing Practices (GMP) Scrupulous attention to detail Comfortable working autonomously or collaboratively Methodical, organised, and able to prioritise work effectively Must hold the right to work in the 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 »
diagnosing and correcting equipment issues, Assist with root cause analysis to promote future reliability Proactive involvement in Continuous Improvement initiatives. Uphold high standards in GMP, Food Safety and Health & Safety, to ensure a secure and compliant work environment. Keep your skills updated to the latest available technologies available. The rotating more »
QA Auditors in monitoring and evaluating product and processing systems. Duties To participate and direct QA team to observe and audit production processes and GMP ensuring products are made to specification and within customer codes of practice and Bakkavor standards, reporting findings to managers as appropriate To ensure products and … Line Manager, manage QA activities required to deliver improvement of Technical KPIs e.g. audit of non-conforming processes, complaint investigations, update of swab schedules, GMP audits, glass and plastic audits. Lead, motivate and inspire QA team to achieve personal development and continuous improvement To promote a quality culture and help more »
Bourne, Lincolnshire, East Midlands, United Kingdom
Bakkavor
which will include some weekend working as set by the rota. Day to day duties will be: To audit compliance against Quality Management Systems, GMP and HACCP controls, raising all non-conformances against relevant standards with objective evidence. Effectively communicating to enable the operational teams to take the appropriate and 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 »
you will be responsible for testing and reporting laboratory activities to enable compliant, on time delivery of products to the customer whilst adhering to GMP standards. Your contribution will be the regular completion of on the bench testing of Asthma Inhalers (MDIs). You will be part of a quality more »
Huddersfield, West Yorkshire, Yorkshire, United Kingdom Hybrid / WFH Options
Thornton Ross
and supply chain as well as external partners like CDMOs to achieve objectives and ensure adequate product availability for launch. Ensure compliance with regulatory & GMP/GDP requirements for generic & specialty drug launches in relevant markets. Establish key performance indicators (KPIs) to track launch performance and evaluate post launch success more »
who is adaptable, can show initiative and pick up lots of new skills quickly Good general laboratory experience, ideally with GLP and/or GMP certification For the chance to join an exciting company on their journey to change the world for the better, please apply today! Bond Williams Professional 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 »
and improvement of the Quality Management System (QMS). Assure the compliance of all activities with Good Distribution Practice (GDP) and GoodManufacturingpractice (GMP) requirements. Responding to medical information enquiries from healthcare professionals, community pharmacies, patients, and wholesalers. Ensuring the completion of checks for new products; having the appropriate 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 »
Governance Team, you will contribute to the provision, continuous improvement, and delivery of a World Class service to the site, ensuring statutory, regulatory and GMP Compliance requirements are met. Accountabilities: As an Accountable Engineer, you will establish collaborative ways of working to build and manage strong internal customer & supplier relationships. 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 you. Main duties of the job To assemble and prepare pharmaceutical products in accordance with relevant Standard Operating ProceduresPrepare, in accordance with GoodManufacturingPractice, Aseptic injectables using isolator technologyTo accurately record and maintain all elements of paper-work related to the preparation of products and maintenance of the … Services and support the delivery of their trainingTo assist in the maintenance of the environment, ensuring that the cleanliness of the facility is to GMP standards About us North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from … procedures Undertakes the physical and microbiological environmental monitoring associated with the facility. Undertakes the regular daily cleaning of the aseptic facility in accordance with GMP and departmental procedures Undertake the monthly and 3 monthly deep clean processes. Assemble non-sterile packs of emergency medication in line with departmental procedures and more »
values, promoting an ethical, positive company culture To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), GoodManufacturingPractice (GMP), Data Integrity (DI), quality and best practice requirements To work collaboratively with Pharma and Health Tech leadership team to develop a Sustainability Roadmap that supports 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 »
Fixed term contract. Introduction to Role: Join our operations team and contribute to the completion of basic manufacturing support processes in compliance with AZ, GMP & SHE standards. Be part of shaping the future of Operations here at AstraZeneca. Accountabilities: As a Process Operator, you will promote an environment of safety … performance, proactively use STOP cards to identify SHE hazards and take appropriate actions. Essential Skills/Experience: - Basic knowledge of procedures and compliance with GMP & SHE requirements - Operational knowledge of specific equipment within the local plant area. This could include a requirement for a Fork lift truck driving licence - Capability 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 »
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 »
and updating risk assessments and risk mitigation procedures. Train necessary staff in relevant fields related to technical compliance. Implement and deliver site quality and GMP compliance metrics: tracking and investigating consumer complaints, internal and external audit outcomes, and customer compliance. Deliver successful customer and external audits: completion of a gap more »