the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and GoodManufacturingPractice (GMP). • Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint … Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and GoodManufacturingPractice (GMP). • Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook. • All other essential duties as directed more »
be paid on a competitive hourly rate. Experience: A minimum of 3 years in sterile drug product development and/or manufacturing Experience in GMP is essential Experienced in liquid product development under aseptic conditions is required Strong technical and practical experience of downstream processing/DSP/DP An more »
and on occasions as required If you would like to discuss this further, please contact Mark Bux-Ryan for further information. QP, qualified, person, GMP, manufacturing, sterile, terminally, sterility, aseptic, quality, assurance, manager, leader, MHRA, audit, release more »
processes adhere to quality standards and regulatory guidelines. Requirements: High School Diploma or Equivalent qualifications to meet the demands of document control in a GMP-compliant manufacturing environment, such as a pharmaceutical or biotechnology facility. Certifications related to document control, quality management systems, or regulatory compliance 5+ Years of Experience … and other relevant tools Attention to detail and accuracy are essential for ensuring the integrity and compliance of documentation. Familiarity with GoodManufacturing Practices (GMP) or other relevant regulatory standards If you have experience in CQV, Doc Control, Turnover, Clean Utilities, Process Engineering, Documentation, HVAC, E&I, or Automation please more »
This is a fantastic opportunity to work alongside our industry leading scientists in our GMP accredited laboratories, at our Sandwich facilities (Kent). You will gain a wide range of practical laboratory skills which are supported by our in-house training. Within the Analytical Sciences department in Sandwich, Kent we … of which used to support batch release, and regulatory packages. As such, you will be trained in all these techniques and general AMS and GMP procedures. There will also be a chance to undertake research for Solid Form Screening using some of the abovementioned methodologies. You will be trained to 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 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 »
Alexander Mann Solutions - Public Sector Resourcing
like something that you would be interested in, please click the link to apply or get in touch with Rebecca Nolan DE&I commitment GMP guarantees to interview all candidates who have a disability and who meet all the essential criteria for the vacancy. In cases where we have a more »
Material & Production Planning master data Prior knowledge of manufacturing, production planning & forecasting Have previous experience in a support environment Experience in companies manufacturing to GMP Standards Knowledge of SQL Experience in analytics/dashboarding more »
Crewe, Cheshire, North West, United Kingdom Hybrid / WFH Options
Bespak
and equipment automationsystems at our Holmes Chapel site. You'll provide hardware and softwaresupport, resolve breakdowns, implement preventative maintenance, and ensurecompliance with GMP (GoodManufacturingPractice), EHS, and company standards.Your role also involves supporting computer system validation, qualityimprovement initiatives, and training other team members. This is a hands-onrole where … support to maintain system performance. Provide hardware,software, and coding support to maintain system performance. Resolve equipmentbreakdowns and conduct root cause analysis. Ensure compliancewith GMP, EHS, and company standards. Support computersystem validation and lifecycle management. Contribute toengineering best practices and project execution. Train team memberson equipment, systems, and procedures. Automation more »
Cambridge University Hospital NHS Foundation Trust
application of Standard Operating Procedures and Quality Assurance Systems. Health and Safety in the Workplace. Maintaining clean and hygienic work environments. GoodManufacturing Practise (GMP) and/or Good Distribution Practices (GDP). Knowledge of stock control systems. Desirable Aseptic dispensing and preparation. Pharmaceutical Science. Contamination Control Systems. Clinical trials more »
Glasgow, Lanarkshire, Scotland, United Kingdom Hybrid / WFH Options
Ernest Gordon Recruitment
Private Healthcare + Free Parking + Life Insurance + Pension + Ongoing Training + Progression Are you a Laboratory Manager with a background in GMP looking to join a company that is passionate about revolutionizing cancer therapy? You will take on a leadership role where you will receive full product … Your duties will encompass supervising production operations, resolving issues in cell culture processes, and spearheading quality investigations. Your meticulous oversight will ensure adherence to GMP standards and facilitate the seamless integration of novel procedures. This role would suit a Laboratory Manager with a background in GMP looking to join a … role where you will receive full product training, tremendous growth opportunities all while working hybrid. The Role: Manage T cell-based therapy production, maintaining GMP compliance. Lead production, troubleshoot processes, and conduct quality investigations. The Person: Life Sciences or related field background. Regulatory knowledge of T cell Therapy. Demonstrated leadership 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 »
Barnoldswick, Lancashire, North West, United Kingdom
Broughton Group
through both written and verbal channels are essential aspects of the role. Your ability to thrive in both regulated and agile environments, such as GMP and ISO 17025, will be crucial for success. Hours of Work: 40 hrs. Monday – Friday 8-hour days. 30 min lunch break. Development Scientist Requirements … user of standard ‘office' applications Desirable: Experience of method development/validation in a regulated environment Understanding of regulatory requirements such as ICH guidelines, GMP etc Able to troubleshoot problematic separations Experience with statistics packages E&L knowledge Development Scientist Benefits: Salary £27,820 - £40,660 Broughton Day Option of more »
of pharmacist as required3.Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of Good Clinical Practice (GCP), GoodManufacturingPractice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management.4.To participate in the Trust-wide Out of Hours Medicines Advice Service and seven-day medicine supply more »
staff on quality protocols. Responsibilities: Develop and improve quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards (e.g. BRC, GMP) Conduct regular audits and inspections of laboratory and manufacturing processes, equipment, and documentation to identify areas for improvement. Gain expert knowledge of the business management more »
The Role - Development/GC MS/HPLC Scientist The Salary - Competitive The Location - Yorkshire Russell Taylor group has a brand-new opportunity for a chromatography scientist. If you think this role would be of interest, apply now to avoid more »
of working within a Quality Assurance Officer role within a fast-paced environment. You should have at least 2 years' experience of working under GMP or have a degree within a science discipline. Knowledge and understanding of GMP with excellent communication and organisation skills are essential for this role. To … Society, Royal Society of Chemistry or Institute of Biology, GPhC, Science Council. Your duties & responsibilities The final review of pre-manufacture batch documentation, following GMP guidelines. The Approval for Use (final release) of all products manufactured or repackaged according to licensing requirements, GMP and professional discretion Being the primary point … attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved. Ensuring that staff comply with GMP, COSHH and Health and Safety regulations and departmental SOP's. Participating in any rota system that may operate within the product release team in order more »
team. Ensure all Radio pharmacy work complies with statutory regulations and goodpractice codes; the latter including. The EU Guidance on GoodManufacturingPractice (GMP)/Rules and Guidance for Pharmaceutical Manufacturers and Distributors published by the MHRA. Define, in conjunction with the Head of Nuclear Medicine, Radio pharmacy production … relevant business cases, financial planning and clinical governance where new service developments are proposed. Together with the Head of Nuclear Medicine and the trusts GMP Quality controller act as the Trust expert for the safe use and introduction of all radiopharmaceuticals. Manage specialist staff rotas/leave arrangement to ensure … good scientific knowledge (degree level). An in depth knowledge of the theory and practice of radiopharmaceutical production Detailed knowledge of GoodManufacturingPractice (GMP) An in depth knowledge of the practices and procedures associated with the use of radiopharmaceuticals for routine nuclear medicine investigations A good knowledge of the more »
Flint, County of Flintshire, Clwyd, United Kingdom
Start People Ltd
Data Analyst - Power Bi Permanent Salary Circal £32k Mon - Friday We have a very exciting opportunity for a Data Analyst working for a FMCG company in Flintshire. This is an excellent opportunity for the right candidate, that loves to delve 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 »
+ 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 »
/equivalent vocational training and/or have equivalent time served experience within a Quality, Scientific or Engineering environment. Awareness of working in a GMP environment Ability to communicate with all areas of an organisation Perform work in compliance with established procedures Understanding of computer software including Word, Excel and more »