guidelines and methods ensuring quality guidelines are adhered to * Support in routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured * Day to day responsibilities include the following elements of the PQS relating to manufacture and testing of cellular therapies … continuous improvement within team What are we looking for? * Min 2 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment * Experience in providing pragmatic quality advice to manufacturing and quality control functions * Experience writing and reviewing GxP documents (including SOPs) to ensure good documentation … data integrity, GxP, quality and regulatory requirements are met. * Working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products is desirable * A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products more »
and expert teams as SME. Requirements • Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering. • Experience in quality operations in the GMP environment. • Knowledge and understanding of regulatory requirements. • Good knowledge of office tools (e.g. Word, Excel, SAP). • Interested candidates should submit an updated CV. Please more »
QA role in Pharma R&D, Infrastructure and Validation team, you will perform the quality assurance activities and quality oversight of the Validation and GMP facilities management activities performed within Pharma R&D across the UK sites. In this role you will be key in the following areas… • Providing review 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 »
Qualified Person (QP) Pharmaceuticals GMP NE England/London Our NE based pharmaceutical client is actively looking for a Qualified Person to join their successful operations. The successful candidate will be responsible for performing final and legal sign-off of batch records for imported and repackaged pharmaceutical products. This position … as a Qualified Person (articles 48-51, Directive 2001/83/EC , with previous operational QP experience. Additional responsibilities will include : Acting as GMP Subject Matter Expert for QMS site compliance Maintaining QMS systems, leading by example to implement and coordinate updates accordingly. Leading and coaching QA Team Ensuring … all activities are completed in line with GMP and GDP compliance and implementing CAPAs to manage and resolve any Quality issues Leading by example on all Compliance and Quality matters Completing both internal and external audits Communicating with onsite and offsite technical staff and liaising with customers and contract QPs more »
time-served Mechanical Engineer in a manufacturing/engineering . Experience ideally gained over a period of 3+ years in FMCG and/or GMP environment Health and Safety knowledge If this position sounds as if it could be of interest, then please apply here and Jamie Lunn from D 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 … instruments, software packages and other analytical techniques (E.g. Empower 3). Is proficient in problem solving and may have expertise in troubleshooting analytical equipment. GMP experience would be desirable. more »
other DSP, Facebook, Twitter Experience of managing vendor relationships Regularly contributes to platform best practices and campaign processes Experience with Google stack and have GMP & Adwords certifications (desirable) Experience with running campaigns across multiple countries/languages Experience with managing a mid- to large-sized team across a range of more »
also oversee the work of junior QC staff, assist in managing the QC laboratory, and participate in assay transfer activities. This role requires maintaining GMP compliance in the QC laboratory. Key Responsibilities Establish, revise, and maintain procedures for QC testing. Maintain QC systems related to in-process, final drug product … and review of reports. Requirements A BA or BS in Chemistry/Biochemistry/Microbiology or other related science. Experience in a GLP/GMP environment. Computer literacy (including MS Word and Excel). Ability to work well with others. Effective communication skills. Good organizational skills. If you are having 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 »
time. Main responsibilities: Use a range of analytical chemistry techniques- predominantly HPLC Ensuring all analysis and documentation are conducted and recorded in compliance with GMP standards Perform stability study programme activities, storage of in process, and final products samples and retention sample management Working to set protocols within a busy more »
WINDMILL WORKS, KELLEYTHORPE INDUSTRIAL ESTATE, WARFIELD ROAD, KELLEYTHORPE, England
BIO-TECH SOLUTIONS LTD
Creating & managing spreadsheets Answering and receiving phone calls Organising logistics, transportation, parcels & pallets Additional opportunity to learn Laboratory & manufacturing methods Be additionally trained in GMP standards Training Level 3 Apprenticeship in Business Administration consisting of: Level 3 Apprenticeship in Business Administration Level 2 Functional Skills in mathematics (if applicable) Level more »
focus on compliance within a specific bakery, working with the teams to identify non-compliance and full engagement and support to ensure company processes. GMP and procedures are fully understood. Work with the bakeries to ensure compliance with relevant customer standards and codes of practice. Conduct physical factory audits (outside … safety and quality. Ensure that the Quality Management System internal audit schedule is completed, and all actions closed out in a timely manner. Ensure GMP & QA CCP audits are conducted to schedule and any non-conformances raised to bakery management. Verify that close out actions are robust and complete. Communicate more »
Doncaster, South Yorkshire, Yorkshire, United Kingdom
Saria
addition, this role may develop into encompassing the following: Promoting HACCP principles throughout the Group; Carrying out Internal Audits including UKAS (ISO 17025) and GMP audits as required; Assisting with the development and understanding of Food Hygiene Standards and Practices and GMP throughout the Group. Assisting with the development and more »
satisfy the requirements of external agencies. Responsible for timely and accurate reporting of internal Refresco KPIs to the management team. Be responsible for ensuring GMP and Hygiene standards are communicated to the operational teams and processes are in place to effectively monitor and manage them. Partake in site visits and more »
Aylesbury, Buckinghamshire, South East, United Kingdom Hybrid / WFH Options
Medik8
to respond to change environments and high growth, high pressure environments. Experience in managing stakeholders. Ability to track and report issues. Experience & understanding of GMP, FDA & TGA Quality requirements. Culture & Benefits We are fuelled by our commitment to sustainability, quality, efficiency, and an unwavering passion for our customers. Championing solutions more »
Huntingdon, Cambridgeshire, East Anglia, United Kingdom
MM Flowers Ltd
monitoring goodmanufacturing 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 »
Pontefract, West Yorkshire, Yorkshire, United Kingdom
Refresco UK
focus: Actively participate in the implementation of site quality improvement projects, where necessary providing support to train operation teams and monitor project effectiveness. Complete GMP and Hygiene audits to required schedules. Assist in the investigation of consumer complaints and non-confirming items determining root cause and corrective action necessary to more »
area highlighting any stock issues to the engineering team manager To maintain standards of hygiene and good housekeeping appropriate to a quality food manufacturer. GMP standard of workshops and engineers tool boxes is maintained at a high level Be the Engineering point of contact during & out of hours Respond to more »
the wider Quality group at Alba Bioscience, part of AliveDx, and its primary role is to ensure that all aspects of GoodManufacturingPractice (GMP) and Good Documentation Practice (GDP) compliance are met through effective control of the Quality Management System (QMS). The role is a full-time temporary … by the business . Participate in an 'in-house' programme of continuous training and assessment. Conduct all duties in compliance with GoodManufacturingPractice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements including statutory Health & Safety legislation and internal practice. Perform any other duties as reasonably requested from the more »
Market Drayton, Shropshire, West Midlands, United Kingdom
Muller Dairy
and provide corrective action Use root cause analysis to understand and deliver optimal cost maintenance Delivery of the required standards in relation to Engineering GMP and food safety standards Escalate potential consequences to line manager where work may impact on product quality or safety Key skills & experience: Strong engineering qualifications more »
in place to meet legal and statutory requirements. Keep records and provide reports in accordance with good engineering practices to external audit standards. Upholding GMP engineering standards across site, statutory inspections are compliant, and any non-conformances are closed out with root cause analysis to avoid repeat failure. Lead the more »
aseptic and non-sterile products for Portsmouth Hospitals University NHS Trust (PHU), and its external customers. You will be working in accordance with GoodManufacturingPractice in order to maintain the standards required by the Medicines and Healthcare products Regulatory Agency (MHRA), and keep the department's manufacturing licence and … local work instructions Proactive attitude to ongoing training and assessment Desirable Previous experience working with aseptics/pharmaceuticals Knowledge of principles of GMP (goodmanufacturingpractice) and Quality Management Systems Good understanding of principles of aseptic manufacturing Customer care skills Additional criteria Essential Punctual and reliable Self-motivated Desirable Willingness more »
within the Centre for Cell, Gene & Tissue Therapeutics. The post holder will be responsible for establishing a process development team that will support a GMP-compliant lentiviral manufacturing process. They will design and implement novel intermediate scale lentiviral manufacturing techniques in suspension cell bioreactors. The post holder will also develop … new downstream purificiation and packaging systems for the delivery of GMP-compliant lentiviral vectors to the cell manufacturing teams in the CCGTT. The post requires exceptional attention to detail and the ability to work in a systematic manner whilst keeping detailed records and managing junior staff. Main duties of the more »