Supporting seal samples. * Release of components and ingredients to Good Stock. * Ensure all operating areas and equipment are maintained to the required levels of GMP and cleanliness. * Ensure all health and safety and environmental standards are maintained. Key Responsibilities and accountabilities: * Supporting the Quality System and the continual improvement philosophy. more »
as an Operations Compliance Operative . The purpose of the Operations Compliance is to ensure the daily compliance ofmanufacturing operations and adherence to all GMP and quality checks required within themanufacturing areas. The following duties are a guide but are not exhaustive. TheOperations Compliance is responsible for ensuring that the more »
miles from Peterborough and 12 miles from Spalding. About the role. 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 Assist in delivery of site 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 »
data feed. Due diligence on new business transactions. Requirements: Qualified Pensions actuary with experience within a top consultancy or relevant firm. Strong understanding of GMP equalisation, Longevity Swap or risk transfer. Excellent stakeholder skills and ability to lead/drive projects. A tenacity to 'get stuff done' and find ways 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 »
Great Ormond Street Hospital for Children NHS Foundation Trust
has a broad skillset and excellent oral and written communication skills. An individual who has a number of years of experience working in a GMP and QA environment is therefore essential for this post in order to provide the required support and guidance to our Production and QA departments and … Essential Educated to degree level in relevant scientific discipline or equivalent Postgraduate qualification Experience/Knowledge Essential Regulatory requirements pertaining to ATMPs manufacture GoodManufacturingPractice and Good Clinical Practice Thorough understanding of gene and cell-based therapies Thorough understanding of HTA Proven experience of line managing staff Experience of 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 »
provide Self-inspection report/Self inspection CAPA reports. Inform appropriate internal departments on audit results and work with the necessary staff to achieve GMP &GDP compliance. Ensure the implementation of corrective actions that are raised by deviations, internal audit, or regulatory inspection. Provide Navision and Nice label support. Support …/RA Manager Participate in QA/RA projects as and when requested. Skills & experience Previous min. 5 year experience within a Pharmaceutical Industry, GMP/GDP environment and Quality Assurance Proven experience working in quality control/assurance and/or regulatory assurance Proven experience in Quality Management Systems more »
services and ensure that all products are appropriately, efficiently and cost effectively prepared within the unit, according to the Guide to GoodManufacturingPractice (GMP) and that pharmaceutical guidelines relevant to aseptic dispensing (production) and departmental procedures are followed To provide pharmaceutical advice to patients/carers/ward staff … training in Technical Services Registered with the GPhC or relevant professional body Up to date CPD portfolio Knowledge: Essential Understanding of the principles of GMP and QA in Aseptics/Production manufacturing environment Understanding of Pharmaceutical Quality Systems Knowledge of Audit and validation Computer and IT competent COSHH Regulations and … Cato aseptic workflow system Experience: Essential Post qualification experience (at least 2 of which have been in hospital preparative services)Working in a Pharmaceutical GMPmanufacturing facility or in a manufacturing environment that employs a quality system (Previous Production/Aseptic experience). Demonstrate ability to deliver induction and competency more »
Hull, North Humberside, North East, United Kingdom
Umbilical Ltd
and maintenance of the company's Quality Management System (QMS) in accordance with regulatory requirements. Assist in conducting internal audits to assess compliance with GMP/GDP standards and company policies. Participate in the review and approval of GMP documentation, including batch records, SOPs, and change controls. Assist in deviation … Bachelor's degree in Pharmacy, Chemistry, or related field. Some experience or internship in a pharmaceutical quality assurance role is preferred. Basic knowledge of GMP/GDP regulations and quality management systems. Strong analytical and problem-solving skills, with attention to detail. Effective communication and interpersonal skills. Ability to work 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 »
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Real Staffing Group
qualified), with practical QP experience in a UK pharmaceutical setting, certifying product to market Knowledge of relevant EU legislation, particularly around goodmanufacturingpractice (GMP), with experience working in a fast-paced, high volume environment Certifying multiple dosage forms would be beneficial, but solid dose and steriles experience would be 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 »
development. Work with the project and business development managers from receipt of RFPS to develop firm proposals and subsequent project delivery. Ensure current GoodManufacturingPractice (cGMP) compliance. Maintain a safe working environment compliant with all relevant Environment, Health and Safety (EHS) requirements. Maintain and expand the cGMP QC services … and product specifications, Certificates of testing, Stability Study Protocols, Method Qualification Protocols and Reports. Manage the ongoing environmental monitoring and water testing of the GMP facility and operation. Manage the investigation of out-of-trend (OOT), out-of-specification (OOS) and any deviation events. Ensure that all regulatory expectations are … met regarding any GMP QC samples or data collected, manipulated, reported, stored or archived. Provide timely and accurate testing updates for materials, samples, products and stability studies to internal parties and external clients. Has budgetary responsibility for the QC department including management of spend and equipment capital expenditure ensuring development more »
Clydebank, Dunbartonshire, Scotland, United Kingdom
SGS United Kingdom Limited
operating procedures currently in use, and verifying that study documentation meets the requirements for compliance with Good Laboratory Practice (GLP) and GoodManufacturingPractice (GMP) standards. You will manage your workload to ensure that tasks are adequately resourced and scheduled efficiently and effectively, with all work audited and carried out … in line with GLP and GMP principles. You will provide compliance advice and guidance to staff when needed and support Study Directors in resolving issues and discussing projects with clients. Additionally, you will engage with clients regarding any deviations, investigations, or out-of-specification events to ensure that any resulting 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 »
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 »
research organisations (CROs), staff an patients in accordance with current UK Clinical Trials Regulations and all amendments, Good Clinical Practice (GCP), GoodManufacturingPractice (GMP), Good Distribution Practice (GDP) guidelines and department procedures. The postholder will support the pharmacy set-up, maintenance, delivery (including dispensing) close-down, archiving and invoicing … include the following: To maintain and support the Pharmacy Clinical Trials service in accordance with current UK Clinical Trials Regulations and all updates, GCP, GMP, GDP guidelines and departmental procedures Performing the operational set-up of all new clinical trials. Day-to-day IMP management activities including shipment receipt, accountability more »