23 GMP Jobs in the East of England

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

renowned for their commitment to excellence. Role Overview: As a Senior Project Manager, you will oversee the entire project lifecycle, focusing on Grade C GMP cleanrooms for this Micro Bio Pharma facility. From initial feasibility to full construction, commissioning, and qualification, you will ensure projects meet the highest standards of more »

and operational support OR 3+ years in a similar role with Manufacturing OT equipment, in Healthcare/Pharma. 3+ years working with GxP and GMP environments. If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lauren.mckinley@skillsalliance.com. 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 »

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 »

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 »

Analyst/Team Leader with extensive experience (3+ years) of using and troubleshooting the above types of Dissolution/Tablet Testing equipment in a GMP environment who is motivated to progress into an exciting Dissolution Field Service Engineer role?! If you said yes to the above, then this brand-new 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 »

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 »

within a multi-disciplinary team to take a tactical role in the design, implementation, and establishment of suitable governance processes to assure the consistent GMP compliance of the CGT Catapult Stevenage GMP facility for cell and gene therapy. Participate in the preparation for and the management of regulatory agency and … and support the evolution of the quality culture throughout CGT Catapult and to train employees in quality related activities where appropriate. Maintain processes, including GMP document control and training, needed for successful site compliance to the QMS. Participate in the review the performance of the QMS at planned intervals and … provide regular reporting to ensure its continuing suitability, adequacy and effectiveness and propose improvements. Participate in the execution of a GMP internal audit programme including the identification and implementation of appropriate corrective actions and a process to track their completion. Experience: Demonstrable experience in an Operational Quality Assurance role providing 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 »

their quality department. As a senior quality associate, you will play a key part of a team that is responsible for quality oversight of GMP and compliance within company operations, providing guidance on GMP, GDP and GLP ensuring compliance with internal and external requirements with both ISO 13485 and ISO 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 »

implement software solutions for all aspects of the products. They will assist software development within the team, ensuring best practices to medical device and GMP standards where appropriate. The software engineer at MFX will be a key player in advancing the revolutionary bioprocessing platform for the Cell and Gene Therapy …/hardware interfaces, user interfaces, data logging and presentation. Work with the existing software development team. Follow all relevant medical device directives and EU GMP Annex 11 with regards to software. Keep relevant Quality Management System documentation up to date. Qualifications & Experience: 2+ years of experience creating software for a 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 »