equipment. You can troubleshoot test processes. You can perform periodic equipment inspections and preventative maintenance work. Your Experience: Lab-based experience would be advantageous GMP or GDP experience You will have high attention to detail Able to work both on individual tasks and as part of a wider team IT more »
to help our patients. We value and encourage learning and development. As the Quality Assurance officer you will support the QA Manager in overseeing GMP compliance, contribute to the management of QMS and ensure the maintenance of quality certifications and standards throughout the manufacturing, testing and release of the product. … companies QMS. · Support with assessment of deviation event investigations. · Support closure to plan of Change Controls and CAPA actions. · Issue, review and approval of GMP batch manufacturing records to support certification and release. · Assist in performance of internal self-inspection audits. · Support the Company’s Quality Meetings. · Assist in maintaining … the Company’s quality certifications, e.g. GMP, GDP, HO approvals, etc. · Assist in preparation for inspections from MHRA and other Competent Authorities · Provide quality review and input to manufacturing and business activities. · Ensure compliance with the Company’s Quality Standards. · Engage with the wider team and sector to gain wider more »
of the highest standard. Main duties of the job To be responsible for supporting the delivery of the PMU Clinical Trials service within the GMP and GCP legislative framework. To provide expert input into all aspects of the Clinical Trial process from liaising with Sponsors, set up and manufacture of … of Clinical Trial medicines to ensure a safe and efficient service. To ensure that all IMP activities undertaken within the Production Unit comply with GMP/GDP/GCP, Health and Safety and COSHH legislation and that all work documentation and procedure manuals meet these regulations. To support senior staff … in the tasks they undertake. Clinical trials To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure GMP, GCP, full protocol, CTA, and IMPD compliance. To generate quality technical agreements, commercial and supply agreements in response to acceptance of a clinical trial, liaising 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 »
and validation of analytical test methods in accordance with regulatory guidelines. Support, release and stability testing performed in-house and at CROs and direct GMP investigations. Develop strategies for evaluating and implementing new technologies within Analytical Development. Support process development, setting of specifications and regulatory filings and responses. Participate in … a relevant biological science. Post-graduate degree in biochemistry or related science is preferred. Experience in a cGMP Quality environment. Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development. Thorough understanding of current regulatory requirements and practical experience more »
activities within the pharmacy department are managed in accordance with the International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), GoodmanufacturingPractice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004. Please note: if you are appointed … oWorking in a Pharmacy environment oClinical Trials oHospital experience oDispensing experience oReconstitution experience oPrevious aseptic environment experience oGood ManufacturingPractice oStores handling oExperience of GMP oGCP Training Skills Essential oIT skills oGood communication skills oAble to work alone and as part of a team. oAn accurate and logical approach to more »
East Kent Hospitals University NHS Foundation Trust
risk assessments Experience of participating in audits/internal monitoring Desirable Knowledge of regulatory requirements relating to clinical trials Awareness of GoodManufacturingPractice (GMP) inc Annex 13 labelling requirements Personal/Professional attributes Essential Excellent attention to detail. High level of initiative Able to problem solve Able to work more »
a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & GoodManufacturingPractice (GMP) FDA21 CFR Part 820. Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering/manufacturing problems, as well 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 »
selecting and acquiring equipment to ensuring its proper validation. Providing technical support to Manufacturing Operations during troubleshooting and investigations. Conducting data integrity assessments for GMP equipment , safeguarding the accuracy and reliability of collected data. Maintaining the qualification life-cycle of all GMP equipment by performing re-qualification activities as necessary. … a Doctorate (PhD) in a Life Science or Engineering field. Proven experience in validating manufacturing equipment and processes. Solid understanding of GoodManufacturing Practices (GMP) regulations. Experience in collaborating effectively with internal and external stakeholders. Adept at multitasking and thriving in a busy environment. Strong relationship builder with excellent communication more »
disposition. The QA officer will ensure assigned tasks are performed in a timely manner to meet batch disposition, supply chain and all associated international GMP/GDP requirements. Key Responsibilities will include: To compile & review batch document sets for completeness & compliance to EU GMP, Pfizer internal requirements and regulatory dossier … s degree in a related scientific discipline with relevant experience (Preferably Biology/Chemistry/Pharmacy/Life Sciences) 2-3 years in a GMP environment Basic experience in pharmaceutical manufacturing, distribution, and control measures Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial. Experience in operating more »
Bourne, Lincolnshire, East Midlands, United Kingdom
Bakkavor
include understanding and applying relevant standards so that Bakkavor, Customer and Legal requirements are achieved and maintained. This role is key to driving improve GMP standards and audit results across the site. You will influence and work collaboratively with the operational teams and agree solutions together. Duties include: To participate … and direct QA team to observe and audit production processes and GMP ensuring products are made to specification and within customer codes of practice and Bakkavor standards, reporting findings to managers as appropriate To ensure products and ingredients are evaluated against specification To assist in delivery of site standards for … Line Manager, manage QA activities required to deliver improvement of Technical KPIs e.g. audit of non-conforming processes, complaint investigations, update of swab schedules, GMP audits, glass and plastic audits. Lead, motivate and inspire QA team to achieve personal development and continuous improvement To promote a quality culture and help more »
with our long standing client in Bristol at an exciting time in their business where they will be commissioning a new GoodManufacturingPractice (GMP) facility. This will be in a new building and be a blank canvas for the new Quality Assurance and Validation Engineer to work on! You … will be working with colleagues both internal and external on commissioning and qualification of this new GMP facility. This will include equipment IQ/OQ/PQ activities, as well as validation and qualification of the ISO 7 and ISO 8 cleanrooms. You will be responsible broadly for all systems … self motivated with a can-do approach. Your background: Bachelors Degree in science or engineering with experience in facilities and equipment validation. Experience of GMPmanufacturing, facilities, equipment qualifications and process validations, including cleanrooms. Knowledge of cGMP manufacturing regulations for the MHRA, FDA and other countries as required. Experience in more »
searching for a Lead Qualified Person (QP) to join a leading Pharmaceutical manufacturer in Northern England. As the Lead Qualified Person, you will ensure GMP compliance for the site and focus on the release of small molecule batches. Your responsibilities as the Qualified Person will be: The batch certification and … on manufacturing floor GEMBA walks. To provide support, guidance and advice on Quality matters to all departments within the company, contributing to the company GMP strategy. The successful candidate for the Qualified Person position will demonstrate the following: Extensive experience in Quality Assurance roles within the Pharmaceutical industry, with on … agile and flexible to enable them to adapt to situations when required. Quality Assurance | QA | QP | Qualified Person | Deviations | OOS | OOT | GEMBA | GMP | GoodManufacturingPractice | Orange Guide | Small molecule more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
s products. Provide US and European regulatory intelligence, train Subject Matter Experts and provide internal consultancy for quality compliance implementation and FDA/EU GMP/GDP remediation projects in the Dechra Internal Manufacturing network. Frequent global travel is required with this role. Main Responsibilities So, what will you be … manufacturing network (as required) across the product's registered lifecycle in compliance with all applicable ISO, ICH, FDA, EU, and national regulatory requirements for GMP/GDP. Lead GMP/GDP audits for Dechra DPMS based on specific expertise, criticality, and complexity. Periodically assess the liability, regulatory and/or … networks are all being adequately monitored. Recruit, lead, train and develop, as required, the team of quality and compliance experts (specialised in auditing different GMP/GDP areas) across the business, to keep the business abreast of ongoing developments through benchmarking activities, whilst proactively identifying and addressing any gaps relating more »
QA Auditors in monitoring and evaluating product and processing systems. Duties To participate and direct QA team to observe and audit production processes and GMP ensuring products are made to specification and within customer codes of practice and Bakkavor standards, reporting findings to managers as appropriate To ensure products and … Line Manager, manage QA activities required to deliver improvement of Technical KPIs e.g. audit of non-conforming processes, complaint investigations, update of swab schedules, GMP audits, glass and plastic audits. Lead, motivate and inspire QA team to achieve personal development and continuous improvement To promote a quality culture and help 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 »
naturally a flexible mindset is needed for this type of position. As such, I am interested in speaking with people from Production and QC GMP settings, as well as fresh graduates looking to get that key break. This team is very open to your background – it is all about your … experience would be advantageous but is not essential Experience and/or understanding of chromatography techniques including HPLC and GC. A solid understanding of GMP principles – or at least the ability to work to strict regulated procedures Flexible to work shifts Must have own transport to access the site due … to shift work QC, quality, control, analyst, analytical, laboratory, radiopharmaceutical, GMP, entry, graduate, science, pharmaceutical, biotechnology, manufacturing, shift more »
naturally a flexible mindset is needed for this type of position. As such, I am interested in speaking with people from Production and QC GMP settings, as well as fresh graduates looking to get that key break. This team is very open to your background – it is all about your … experience would be advantageous but is not essential Experience and/or understanding of chromatography techniques including HPLC and GC. A solid understanding of GMP principles – or at least the ability to work to strict regulated procedures Flexible to work shifts Must have own transport to access the site due … to shift work QC, quality, control, analyst, analytical, laboratory, radiopharmaceutical, GMP, entry, graduate, science, pharmaceutical, biotechnology, manufacturing, shift 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 »
Stockport, Greater Manchester, 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 »
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 »
global pharmaceutical company who require a QA Production Support Supervisor/RP to join their well-established Quality and Operations team, focusing on the GMP and GDP requirements. This role involves the supervision and mentoring of a team of very capable Quality Assurance Production Support Officers. Responsibilities: Qualified RP/… systems (including, but not limited to the complaints and batch release processes) Write, implement, review and maintain SOPs, policies and other documentation for QA GMP and GDP activities. Act as Quality GMP and GDP advisor on site projects such as new product introductions or CAPEX projects. Host training sessions on … GMP and GDP QA related topics. Requirements Extensive GMP Quality Assurance experience, preferably in production support Experience of line management and leadership Qualified RP/RPi SRG is UK’s number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices more »
ABOUT YOU Are you a Quality professional with experience in a GMP laboratory, looking for a role that will challenge you, and help you develop new skills? You will possess rigorous attention to detail and be hungry for a challenge out of the lab. We need you to have: BSc …/MSc/PhD in Chemistry (or related scientific discipline) A sound working knowledge of relevant quality standards; GMP, GLP, GCP and other analytical related quality standards Good working knowledge of Quality Assurance in the Chemical and Pharmaceutical Industry Quality Assurance background which includes some specialist knowledge within a defined … Excellent attention to detail Impressive written and verbal communication ABOUT THE OPPORTUNITY You will provide general support to Quality Assurance activities relating to GLP, GMP, GCP, and other similar Quality Systems established to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved. more »
