Stevenage, England, United Kingdom Hybrid / WFH Options
Workday
GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMPmanufacturing, 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 »
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 »
following areas: Supplier & raw material controls, Process Validation, Equipment (Qualification, SOPs, Software Validation) 🔹 Your qualifications: Strong background in Software Validation Quality Management Systems ISO13485 GMP Experience working with IVD/Medical Devices ✉️ If you are interested in this exciting role, please send your application directly to ahmed@elemed.eu 📲 Would you more »
been compiled and approved at gate reviews. Good Engineering Practices (GEP) are employed in the design, installation and commissioning of assets. GoodManufacturing Practices (GMP) are employed, including activities determined from user requirement specifications (URS) through to qualification. Approval of GxP documentation, including technical specifications, user requirements, design/code 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 »
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 »
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 »
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 »
Hoddesdon, Hertfordshire, South East, United Kingdom
PHARMARON UK LIMITED
focused Extremely safety conscious Helpful and responsive and committed to delivering the very best Team playing whilst proactive and a self-starter Desirable Requirements: GMPmanufacturing 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 GoodManufacturingPractice (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 »
Hatfield, England, United Kingdom Hybrid / WFH Options
Planet Pharma
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. General Responsibilities (Safety, Quality, Customer, Cost and Innovation) • To ensure that operations conducted are performed in accordance with the requirements of corporate standards … within the production facility. • Management of the design, development, maintenance and troubleshooting of automated systems, ensuring they are compliant as per GAMP5 and EU GMP Annex 11. • Successful delivery of automation projects to meet strategic business objectives. • Execute or facilitate automation design solutions in accordance with stakeholder requirements and business … at gate reviews. • Responsible that Good Engineering Practices (GEP) are employed in the design, installation and commissioning of assets. • Responsible that GoodManufacturing Practices (GMP) are employed, including activities determined from user requirement specifications (URS) through to qualification. • Coordination of specialist contractors undertaking work packages, ensuring safe systems of work 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 »
recommendations and actions. Perform high-level static and dynamic maintenance on all equipment. Contribute to continuous improvement initiatives. Ensure compliance with GoodManufacturingPractice (GMP) standards. Assist the Engineering Manager with projects and ensure site compliance with Safety, Health, and Environmental legislation. Manage contractors on site and coordinate activities during 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 »
will be varied however the key duties and responsibilities are as follows: 1. Calibration of utility, process and laboratory instrumentation. 2. Maintain and use GMP documentation for all aspects of the job in accordance with working in a pharmaceutical environment. 3. Aid with Installation, Operational, and Process Qualification processes for … conductivity, level and weight sensors. 3. A working knowledge and practical experience within the highly regulated manufacturing industries: Key Words: Engineer | Technician | Calibration | Pharmaceutical | GMP Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for more »