that would be advantageous: Experience in developing and implementing continuous improvement initiatives Experience using QPulse or equivalent eQMS system Experience of Pharmaceutical Regulatory Agency GMP inspections (e.g., MHRA, FDA, UKAS) The ideal candidate should have the following qualities and skills: Excellent interpersonal skills with the ability to communicate effectively with more »
London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
for purpose QMS. Conduct GCP process, vendor, and investigator site audits. Support GxP Quality needs in Development & Precision functions, e.g. GVP, GLP, GDP/GMP & CSV. Requirements: Strong GCP Quality experience in biotech/pharma which spans clinical trial phases I to III. Expert in GCP global regulations and guidance more »
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 »
maintain all relevant documentation to ensure you are complying with the BS EN ISO 14644 clean room requirements, BS EN ISO 9001 and some GMP standards. Ensure compliance with all company health and safety rules and regulations at all times, including contributing to any company health and safety initiatives and more »
primarily capital equipment and changes to scope) with internal resources and liaises with the Business Manager to ensure client agreement and payment. Align with GMP requirements and company rules, policies and procedures. Understand emergency procedures and align with safe systems of work. Ensure compliance with environment, health and safety rules more »
background Awareness of Engineering and operational data systems and lifecycle management Experience in the development and deployment of industrial automation platforms Experience within a GMP operations environment Possess a blend of data architecture, data analysis and practical operations experience Desirable Skills/Experience: Business case creation Conceptual, analytical and strategic more »
required certifications): Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering; Min. 5 years of experience in quality operations in the GMP environment; Other languages are an asset; Knowledge and understanding of regulatory requirements; Good knowledge in office tools (e.g. Word, Excel, SAP). Additional Preferences: Working more »
or related field; advanced degree preferred. Minimum of 5 years of experience in quality assurance within the pharmaceutical industry, with a strong understanding of GMP, GLP, and GCP regulations. Proven track record of implementing quality systems, managing deviations, and driving continuous improvement initiatives. Excellent communication, problem-solving, and leadership skills. more »
requirements, including the following activities: · definition in collaboration with key stakeholders of the validation strategy following a risk-based approach and ensuring regulatory and GMP requirements are met Preparation of Validation Plans and protocols in line with defined and approved validation strategy and company templates, coordinating the review and approval more »
of Quality Assurance principles within the Pharmaceutical Industry. Strong understanding of Quality Management Systems in the pharmaceutical sector. Thorough familiarity with ICH-GCP and GMP guidelines. Experience in hosting Sponsor audits and/or Regulatory inspections. Demonstrated ability to organize and conduct internal and/or vendor audits. more »
released for sale or further processing align with cGMP standards, product quality specifications, and regulatory requirements. You will review and approve related technical/GMP documents, collate and interpret data, provide independent assurance of the maintenance of appropriate quality standards, and make product and material release decisions. You will also more »
Sheffield, South Yorkshire, Yorkshire, United Kingdom
MK Business Support Ltd - Engineering
Experienced in managing internal and external resource to ensure project activities are completed on time, to budget and the required specification. Working knowledge of GMP requirements for facilities and equipment desired. Manage external contractors whilst adhering to safe working practice and specific HSE requirements. Demonstratable management experience of multiple concurrent more »
Loughborough, Leicestershire, East Midlands, United Kingdom
Almac Group (Uk) Ltd
Knowledge of cGMP and manufacturing processes of pharmaceutical products Experience in technical work and/or significant hands on experience in pharmaceutical development and GMP manufacture Knowledge and application of Lean Manufacturing Principles Experience of working to aggressive timelines Reward For the successful candidate, we offer an attractive benefits package 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 »
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 »
Alfreton, Derbyshire, East Midlands, United Kingdom
AMS PEOPLE LIMITED
device or similarregulated sectors with a Total Quality Management approach. - Experience in the application and management of Quality Management Systems to meet ISO, FDA, GMP etc. requirements. - Ability to implement company systems, processes and policies with consistency, being a key presence on site championing quality assurance and quality improvement initiatives more »
equivalent) or a Masters with relevant industry or clinical laboratory experience highly desirable Experience working in a regulated lab environment (GLP/GCP/GMP) is highly desirable Experience with cell culture including cell lines and primary human immune cells Experience with multiparameter flow cytometry Experience with developing and running more »
ideal candidate you will have excellent knowledge of quality assurance and quality management systems within the pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines and as well working experience hosting sponsor audits and/or regulatory inspections. Experience organising and performing internal and/or vendor audits. more »
in industry? Or do you already have a background in an industrial chemistry lab but would like to develop your skills further in a GMP environment? SRG Synergy are currently working with a world-leading pharmaceutical organisation located in Ware with a vacancy for a QC Analyst – Level 1 Synergy 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 »
Northampton, Northamptonshire, East Midlands Hybrid / WFH Options
Real Staffing
change control and complaints Skills/Qualifications Eligible to act as an RP, ability to act as RPi also desirable Knowledge of GDP and GMP requirements Knowledge and experience with Medical Device Ideally degree Level education or equivalent practical experience On offer Salary + Bonus and Benefits Package Hybrid Working 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 »
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 »
Worksop, Nottinghamshire, East Midlands, United Kingdom
Samworth Brothers Limited
with other functions (Operations, Process, NPD Engineering and Raw Materials) to deliver them. To ensure daily/weekly/monthly QA scheduled tasks (i.e GMP, calibrations, audits and sampling) are completed on time and any subsequent actions are followed up. To conduct investigations into non conformance , agree corrective actions and more »
Quality Assurance team in conjunction with other business functions. Host site Client Audits and Regulatory Inspections. Requirements: Minimum of 5 years working in a GMP environment, within a Quality Assurance function. Graduate, preferably in Chemistry, Pharmacy or Biological Science. Significant experience of working in a leadership Pharmaceutical Quality Assurance role. more »