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 »
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 »
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 »
trial design, to advise them on goodpractice in accordance with the International Conference on Harmonisation (ICH) guidelines on Good Clinical practice and GoodManufacturingPractice and on the regulatory status of the clinical trial drug. 5. To lead and finalise the set-up of cancer clinical trials, i.e. writing … years post-graduate training above original Masters level qualification) Vocational Masters degree in Pharmacy (4yrs) and 1 years pre-registration training and experience) GMP accredited Desirable Specialist qualification in cancer therapy or equivalent knowledge Qualified Independent Prescriber or willing to undertake training Experience Essential Substantial post registration experience in a 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 »
want you to join a leading food company dedicated to delivering excellence in every way! You will be responsible for delivering high levels of GMP, food safety and integrity standards. Responsibilities Include: • Supporting the overall technical strategy, tactics, policy & plans • Responsible for the company’s quality management system to ensure … Responsible for the internal audit programme of the business • Lead the site HACCP programme • Manage non-conformance investigation and resolution • Effective management of the GMP auditing system • To provide leadership to the technical team. Ensuring personal objectives are met. • To ensure a positive working environment • Working alongside all the other more »
Senior Actuarial Analyst - GMP London £40,000 - £60,000 per annum Leading mid-sized consultancy in their search for a Senior Actuarial Analyst to join their actuarial technical team | Those wanting to stop or have stopped sitting actuarial exams will also be considered. Company client is working with a leading … mid-sized consultancy in their search for a Senior Actuarial Analyst to join their actuarial technical team with a focus on the delivery of GMP equalisation projects. Within this role, you will check technical calculations, provide technical expertise and support to client teams with a dominant focus on GMP work. … Although GMP work will be your main focus initially, over time this business will incorporate similar technical project work into your role as the demand for specific GMP work reduces. Role requirements: * Part-qualified actuary or technical equivalent skill-set with a desire to not. * GMP equalisation calculation experience, or 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 »
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 »
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 »
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 »
