22 GMP Jobs in the East of England

Senior QA Officer required for a cell therapy CDMO who have a state-of-the-art facility based near Cambridge for multiproduct GMP production. This site allows scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the … comparable experience Essential. Proven experience in the field of Cellular Therapies (Biotech/CMO) with experience of working in a QA role in a GMP compliant environment Essential. Experience with performing and managing risk assessments Essential. Experience of performing internal audits Essential. Experience of managing deviations, non-conformances and CAPAs more »

on a permanent basis. The Validation Manager will be leading the validation function to be able to execute report activities within the framework of GMP - Annex 11 & 15 in compliance with QMS requirements. In addition, they will be supporting multiple validation projects, liaising with the project departments and the associated 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 »

responsibility will be to ensure that all materials are tested according to agreed specifications and procedures, in agreed time frames and in accordance to GMP and company guidelines. Other key responsibilities will include to: - Qualify, maintain and calibrate all laboratory equipment according to procedures. - Maintain all laboratory Quality Systems and … Assurance Performance Indicators. Your Background: You are required to have the following qualifications, skills and experience: - Knowledge of Quality Control, Quality Assurance, Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products. - Stability testing experience - Hands-on HPLC experience - Good technical and scientific judgement. - Diplomatic, self-motivating … professional with problem solving and decision-making capabilities. - Basic understanding of GMP Guidelines and Regulations. Apply: For more information, or to apply for this QC Analyst position please contact Hannah Oakley on 01246 457711 or email hoakley@ckgroup.co.uk. Please quote job reference 56706 in all correspondence. It is essential that 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 »

work environment and that all tools are maintained and accounted for. Liaise with the SHEQ team to resolve H&S issues, environmental, internal audits, GMP, COSHH and ISO quality issues, and ensure all compliance checks are complete and correctly filled. Attend all nominated training modules as necessary. Undertaking any other more »

focused Extremely safety conscious Helpful and responsive and committed to delivering the very best Team playing whilst proactive and a self-starter Desirable Requirements: GMP manufacturing equipment Recognised formal qualification in secondary control discipline or equivalent experience in Control Systems Knowledge of high integrity PCS and PLC programming would be … Drug Discovery teams. In addition, a Formulation Development team was also recently established. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), Formulation Development (FD) and Process Chemistry (PC). We offer a competitive salary and a more »

The site Head of Quality will lead the designated site in terms of GMDP quality and compliance, including in the areas of: QA, QC, GMP, GDP, QP activities and RP activities in line with the business goals and plan. Responsibilities: Establish clear and compliant GMDP standards for all site activities 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 »

Comfortable operating autonomously once goals and objectives are set. Excellent interpersonal, written and verbal communication skills. Confidence and ambition to provide pragmatic and considered GMP advice. Having current and up to date professional knowledge, expertise and best practice. Proven ability to engage constructively with colleagues at all levels across different 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 »

deploy software for new products, including software/hardware interfaces, user interfaces, data logging, and presentation. Follow all relevant medical device directives and EU GMP Annex 11. Technical skills needed include: 2 years in a regulated industry or similar, 2 years of experience with writing code in C/C++ 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 »

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 Good Manufacturing 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 »

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 Good Manufacturing practice (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 »

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 »

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 »

the manufacturing teams in these areas. The role will mostly be factory facing and will have responsibilities for auditing compliance against Quality Management Systems, GMP standards, Due Diligence and Customer Standards. Accountabilities : Supporting the Technical Manager in implementing our Food Safety. Quality and Hygiene systems in line with business growth 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 »

safety guidelines and protocols. Continuous Improvement: Driving factory process improvements through techniques like root cause analysis and downtime analysis. Contributing to plant housekeeping and GMP audits and managing logistics team standard tasks. Measures of Success: Clear logistics strategy and plans. Adherence to logistics budget. Decrease in logistic complaints. On-time more »