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 »
Camelford, Cornwall, South West, United Kingdom Hybrid / WFH Options
Saputo Dairy UK
to demonstrate the ability to learn the technical aspects of processes. Able to show an understanding and willingness to comply with all food standards (GMP, health & safety etc.) consistent with working in a world class food manufacturing environment. WE SUPPORT AND CARE FOR OUR EMPLOYEES BY PROVIDING YOU WITH We more »
working. You will manage all company pension schemes and ensure that all legislative requirements are met. This role will involve project work, centred around GMP equalisation buy-in preparations and benefit changes. You will also manage the day-to-day administration of pension schemes. Responsibilities also include communicating and educating more »
QA Manager (m/f/d) - GMP/Quality Risk Management/Qualification/Validation/Parentals/English & German Project: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified QA Manager (m/f/d). Background: The IMP Quality … the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality, Quality Systems and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland. The Clinical Supply Centre in Basel for Parenterals is … responsible for manufacturing Sterile Drug Products for clinical studies. In the course of the implementation of Volume 4 EU Guidelines for GMP Annex 1 (C 5938, 22-Aug-2022) (and PIC/S PE 009-16 GMP Guide, Annex 1), the candidate supports and drives end to end the full 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 »
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 »
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 »
