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 »
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 »
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 »
the site with all HSEQ - Ensuring the maintenance of all external certification (ISO 9001, ISO 45001, ISO 14001, ISO 50001, IATF 16949, AS 9100D & GMP), completing internal/2nd/3rd party audits and inspections, ensuring the completion and closure of non-conformities, investigating customer complaints, collection of site data 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 »
Haematology wards Lead on and develop elements of the clinical pharmacy service to improve the patient experience. Provide release of chemotherapy products according to GMP Facilitate and promote rational and optimal medicines usage Provide assimilated and relevant medicines information to healthcare professionals and patients To participate in the out of more »
from a Pensions background and ideally Team Leading people working on similar projects as listed below. - Pensions Data Transfer - Client Onboarding - Implementation - System Configuration - GMP - BIBO - Buy in - Buy out - Pension projects Unique culture, fully diverse and inclusive, very supportive, with ability to grow and become senior manager. Responsibilities: Takes more »
bench to bedside concept.Working under the trusts Pharmaceutical Quality System, the post holder will use their experience and specialist knowledge in GoodManufacturingPractice (GMP), immune cell culture, immune cell purification by high end multicolour flow Cytometry and or other methods to take responsibility for developing and delivering the manufacturing … expansion. Required to work with collaborators in developing processes by taking pre-clinical ideas and technology transferring to the unit and ensuring phase appropriate GMP compliance Lead Validation and qualification procedures for processes and equipments used for manufacture of immune cell products3 Provide specialist knowledge of the latest developments within … implementing independently controlled documents: Investigational Medicinal Product Dossiers, Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures (SOPs) for Production activities in the GMP unit. Ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM) Undertake strategic judgements based upon specialist knowledge of the more »
x2). You will also get 25 days holiday and an enhanced pension. The role is to support production and manufacturing tasks working to GMP (goodmanufacturing practices) . The Role: Permanent, full time position working mainly days and occassional nights as a General operative within manufacturing Various production tasks more »
planning, resource and cost management and progress reporting. Your background - experience gained within the pharmaceutical industry - experience of ensuring compliance with all EHS and GMP requirements - experience of writing SOP's - formal engineering qualification - preparation of pre-qualification document for new and retrospective projects -flexibility to travel to alternative sites more »
Risk Management Reports and Files Quality Inspection Procedures and Control Plans Quality Systems and Process SOPs and Work Instructions (PWI). Conduct internal Audits, GMP and process audits, as required. Supervise goods in inspection. To accurately record data, calculate results and file information. To actively participate in the investigation of … requirements. Knowledge of world class quality techniques and implementation. Good working knowledge of validation, data integrity, statistics, technical drawing and tolerancing. Knowledge of GoodManufacturingPractice, Good Laboratory Practice and Quality Systems Strong attention to detail. Familiarity with appropriate software eg Minitab, MS Office, Lotus Notes. Good organisational skills Ability more »
including HR duties eg: PDRs Organising the safe and efficient production of aseptically prepared products Delivering full training to production staff taking part in GMP activities, ensuring proficient and safe working within an Aseptic Services Unit Supporting co-ordination of operator validations and competency checks. Co-ordinating workflow and workforce … precision required for aseptic manipulations. Long periods of concentration performing accuracy checks. Responsibility for Patient Care Maintains compliance with Rules and Guidance to GoodManufacturingPractice and any other local, regional and national guidance documents. Assists with the maintaining Quality Assurance Standards in accordance with National, Regional and local requirements. … and reporting any deficiencies. Responsibilities for Human Resources Supervises Band 4 Technicians and Assistants groups within the aseptic suite to ensure compliance with GoodManufacturingPractice and departmental procedures and protocols. Participates in the recruitment process for Band 4 Pharmacy Technicians, Science Manufacturing Technicians and Assistants. Performs appraisals with junior more »
Lead best practice in the department and become a key contact for the mentoring and training of more junior members of staff. Act as GMP ambassador, take responsibility for ensuring GMP compliance and adoption of GMP principles e.g., right first time. Lead activities to ensure close working with Analytical development … understanding of cell biology and immunology (preferred) Strong verbal and written communication skills. Flexible, self-motivated, and focused on team outcomes. Strong understanding of GMP regulations. Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team, as well as independently. 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 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 »
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 »
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 »
clinical trials and practice research. Experience of supervision of staff. Experience in delivering training and education to staff. Understanding of the principles of GoodManufacturingPractice and Quality Assurance Understanding of Section 10 exemption of the Medicines Act and the requirements that this brings Understanding of Good Clinical Practice and … Band 8a - Sound understanding of the principles of Oncology/haematology Band 8a - Evidence of delivering service improvements. Band 8a - Working knowledge of current GMP and QAAPS standards and legislation. Band 8a - Enhanced knowledge of Good Clinical Practice and experience of handling clinical trial material (IMP) in an aseptic unit. 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 »
always opportunities to learn and gain exposure. Experience: Previous experience in a QA position within a pharmaceutical, healthcare or food setting Working experience of GMP Operational Quality Assurance experience including batch review/release Exposure to handling complaints processes Lifecycle experience of deviations, CAPAs and change controls Strong stakeholder management … Mark Bux-Ryan for further information quality, assurance, QA, QC, control, analytical, chromatography, HPLC, laboratory, documentation, analyst, officer, specialist, executive, administrator, good, manufacturing, practice, GMP, GLP, audit, SOP, training, complaints, batch, review, release, CAPA, deviation, change, control 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 »