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 »
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 »
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 »
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 »
by performing physical and analytical testing and report accurate results. Duties to include: Being responsible for physical analytical testing. Follow internal methodologies. Adherence to GMP requirements. Accurately record microbiological results within data packages, as received. Execution of protocols. Ensure laboratory housekeeping standards are maintained and documented accurately. Ensure all equipment … detail, able to prioritise workload, positive and flexible approach. One to two years' experience in a similar role would be ideal, but not necessary. GMP experience would be desirable. CVs in Word please. New Appointments Group, Expertly Matching Employers and Jobseekers since 1975. Committed to diversity, equality and opportunity for more »
company or CRO Experience on CMC documentation for respiratory devices is important Experience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacture Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory Solid experience … with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines Updated knowledge of ICH GMP is required Excellent communication, presentation, and interpersonal skills. Self-driven and motivated team player Familiar with working in a virtual set-up Fluent in written and spoken English more »
Lab Analyst/Senior Lab Analyst Serving Society through Science, Tata Chemicals Europe (TCE) is one of Europes leading producers of sodium carbonate, salt and sodium bicarbonate and other products, from our plants in Cheshire, UK. British Salt has been more »
products reach every corner of the globe with precision and efficiency. Be the guardian of quality, ensuring every launch meets the gold standard of GMP and GDP regulations. Tackle challenges head-on, turning obstacles into opportunities for innovation and growth. Keep stakeholders in the loop with your expert communication skills … Business, Life Sciences, Engineering). Strong experience in the pharmaceutical realm, where you've honed your project management skills. A deep-seated understanding of GMP and GDP guidelines. A proven track record of launching products would be advantageous. Great communication skills, coupled with the ability to navigate complex challenges with more »