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 »
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 »
site and related functions are in compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have ownership for key quality system elements and will support and execute site quality more »
site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have support key quality system elements and compliance improvements, working closely with relevant stakeholders more »
in using industry-standard software lifecycle management tools such as Jira, Confluence, and AHA! Previous exposure to applying industry compliance and quality standards (GLP, GMP, 21CFRPart11) in software products. Effective communication and stakeholder management skills to facilitate seamless collaboration and alignment across diverse stakeholders. If you possess a passion for more »
the team's size and operational scope. Key qualifications: Extensive experience in Quality Assurance across diverse responsibilities Preferably, a background in pharmaceuticals, though other GMP environments will be considered Bachelor's degree or equivalent in a relevant technical field Strong proficiency across various quality functions such as batch review, investigations … into a senior leadership role within a fast-paced pharmaceutical environment, apply now to become part of a dedicated team. Keywords: Quality, QA, assurance, GMP, manufacturing, distribution, packaging, CDMO, pharmaceutical, batch release, systems, compliance, regulatory, specialist, investigations, CAPA, deviation, change control, operations, senior, leader, supervisor, manager, coach, mentor. 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 »
co-ordinate the day to day workload, ensuring items are manufactured in a timely manner and colleagues are supported. To follow goodmanufacturingpractice (GMP) at all times. To generate worksheets and labels, ensuring medicines are charged correctly using the pharmacy computer system. To in process check worksheets and labels 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 »
Oversee multiple QA projects, ensuring timely and effective execution. Compliance and Quality Assurance: Ensure all operations comply with regulatory standards (MHRA, FDA, etc.) and GMP guidelines. Risk Management: Identify and mitigate risks associated with aseptic processing. Continuous Improvement: Drive initiatives to enhance product quality and operational efficiency. Requirements: Experience: Minimum … and developing a team. Project Management: Strong project management skills, with the ability to handle multiple projects simultaneously. Technical Knowledge: In-depth understanding of GMP, aseptic processing, and regulatory requirements. Communication: Excellent interpersonal and communication skills, with the ability to influence and collaborate across all levels of the organization. Problem 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 »
Job summary The Vaccine Development and Evaluation Centre department, based at UKHSA Porton, is the UK's largest capability for the handling of dangerous human pathogens and animal modelling of infectious diseases. The capability is used to understand pathogenesis and more »
proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products andstability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data. Perform stability study programme activities, storage of in process … timely manner of any failure of calibration Maintain Quality Control information systems Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst Assist in investigation of quality incidents and other problem solving forums and … and conferences where appropriate Carry out general maintenance and house keeping of equipment and laboratories Essential Experience Experience within a QC laboratory working to GMP within a recognised quality system. Ability to organise work within a busy laboratory with experience of writing and working to SOP documentation. Knowledge of GMPmore »
proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products andstability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data. Perform stability study programme activities, storage of in process … timely manner of any failure of calibration Maintain Quality Control information systems Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst Assist in investigation of quality incidents and other problem solving forums and … and conferences where appropriate Carry out general maintenance and house keeping of equipment and laboratories Essential Experience Experience within a QC laboratory working to GMP within a recognised quality system. Ability to organise work within a busy laboratory with experience of writing and working to SOP documentation. Knowledge of GMPmore »
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
under of 'specials' licence. You will have a key role in ensuring all units with Pharmacy Technical Services are compliant to GoodManufacturingPractice (GMP). About us University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a … responsibilities, please refer to the job description document attached to this vacancy. Person Specification Knowledge and Experience Essential Basic knowledge of GoodManufacturingPractice (GMP) Basic knowledge of Good QC Laboratory Practice (GQCLP) Experience of working in a laboratory undertaking analysis Desirable Experience of aseptic preparation Knowledge of COSHH & health more »
Cambridge, Cambridgeshire, East Anglia, United Kingdom
Vector Recruitment Ltd
defining system architect and high-level product specifications to create robust, scalable, and secure solutions with familiarity with OPC-UA, GAMP5, and software for GMP applications Have identified requirements and worked with connectivity to 3rd party systems, both local and cloud based, for manufacturing control systems. Utilised appropriate tools and more »
Cambridge, Trumpington, Cambridgeshire, United Kingdom
Vector Recruitment
defining system architect and high-level product specifications to create robust, scalable, and secure solutions with familiarity with OPC-UA, GAMP5, and software for GMP applications Have identified requirements and worked with connectivity to 3rd party systems, both local and cloud based, for manufacturing control systems. Utilised appropriate tools and more »
Milton Keynes University Hospital NHS Foundation Trust
for the benefit of the service. Interview date: 8th July 2024 Main duties of the job To ensure that all current GoodManufacturingPractice (GMP) Quality Assurance activities are effectively managed to meet agreed Trust and Pharmacy Department objectives whilst complying will all relevant national and local legislation, regulations and more »
of Validation Proven leadership skills. Computer literate with the ability to use CRM systems Experience and knowledge of H&S, COSHH, ISO, GLP and GMP A problem solver Due to the nature of the role, you will need excellent colour vision If you believe you meet the above criteria and more »
factory. Monitoring customers returns and give daily the report to finance team. To ensure that all operatives and staff within the factory comply with GMP and hygiene procedures and to advise and give training when this is not the case. To work effectively within the departmental rota, ensuring all aspects … company procedures and policies. To monitoring, verify and report any issues daily on Day & Night Shifts check list Compliance Audit. To carry out Internal GMP/Glass and Hard Plastic Audit within the factory. Weekly monitoring of all PPE request orders. To ensure that all operatives and staff within the … factory comply with GMP and hygiene procedures and to advise when this is not the case. To actively partake in the resolution of quality related issues. To support training all members of staff in food hygiene, health & safety, manual handling, fire safety, chemical safety, and allergen awareness training. To assist 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 »
of Quality Assurance/Quality Control during times of absence. Responsible for the direct line management of technicians and assistants. Provide initial and refresher GMP training to all aseptic staff, to ensure a thorough understanding of the importance of GMP. Person Specification Qualifications Essential NVQ Level 3 in Pharmacy Services … and Dispensing of Medicines" (or willingness to undertake in first year of role) Current registration with the General Pharmaceutical Council Knowledge and understanding of GMP, GLP and Pharmaceutical Quality Systems Knowledge Essential Demonstrable post qualification experience particularly in the specialised area of Aseptic Services and Pharmacy Quality Assurance Experience of more »