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 »
processes adhere to quality standards and regulatory guidelines. Requirements: High School Diploma or Equivalent qualifications to meet the demands of document control in a GMP-compliant manufacturing environment, such as a pharmaceutical or biotechnology facility. Certifications related to document control, quality management systems, or regulatory compliance 5+ Years of Experience … and other relevant tools Attention to detail and accuracy are essential for ensuring the integrity and compliance of documentation. Familiarity with GoodManufacturing Practices (GMP) or other relevant regulatory standards If you have experience in CQV, Doc Control, Turnover, Clean Utilities, Process Engineering, Documentation, HVAC, E&I, or Automation please more »
a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide leadership to the Quality Teams … the business and provide support to sister company for regulatory inspections and conduct self-inspection program Oversee the Pharmaceutical Management System. Implement the current GMP regulations and industry best practices, where applicable Support and develop the QA team Support/lead manufacturing deviation or testing out-of-specification/out … of-trend investigations Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guideline Qualifications and Skills: Qualified Person (QP) Knowledge and experience in manufacturing and testing of oral dosage forms and topical products Experience in releasing medicinal products in a fast-paced environment Experience in more »
a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide leadership to the Quality Teams … the business and provide support to sister company for regulatory inspections and conduct self-inspection program Oversee the Pharmaceutical Management System. Implement the current GMP regulations and industry best practices, where applicable Support and develop the QA team Support/lead manufacturing deviation or testing out-of-specification/out … of-trend investigations Audit the contract manufacturing organisation and laboratory against EU GMP and relevant regulations and guideline Qualifications and Skills: Qualified Person (QP) Knowledge and experience in manufacturing and testing of oral dosage forms and topical products Experience in releasing medicinal products in a fast-paced environment Experience in more »
Bolton, Greater Manchester, North West, United Kingdom
Russell Taylor Group Ltd
company (part of a large Pharmaceutical group); is looking to strengthen their QA team and recruit a Snr QA Release Officer. This is a GMP focused position and this person will play a key part in the growth and development of the team. Duties will include releasing batches of manufactured … change controls, unplanned deviations). The Person: Will have a Degree in a relevant- Scientific discipline A minimum of 3+ years experience working to GMP in a Pharmaceutical setting Candidates with experience in Laboratory, Production or Pharmacy who are looking to move into a QA role full time are also more »
South East London, England, United Kingdom Hybrid / WFH Options
i-Pharm Consulting
product.The role will be joining the UK team, as a senior individual contributor and part of a global team.Other essential responsibilities include:Management of GMP and GDP complianceManagement of complaints, CAPAs, risk assessments, and validation protocolsReview and manage the QMS systemAble to manage non-compliance issues and escalate when neededHave … the requirement will be that you are able to travel to West London site and to supplier sites.It is a must that you have GMP and GDP experience.The role will be joining a team which is integral to the business and requires strong communication skills. The team are close-knit more »
London, England, United Kingdom Hybrid / WFH Options
i-Pharm Consulting
role will be joining the UK team, as a senior individual contributor and part of a global team. Other essential responsibilities include: Management of GMP and GDP compliance Management of complaints, CAPAs, risk assessments, and validation protocols Review and manage the QMS system Able to manage non-compliance issues and … requirement will be that you are able to travel to West London site and to supplier sites. It is a must that you have GMP and GDP experience. The role will be joining a team which is integral to the business and requires strong communication skills. The team are close 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 »
Responsibilities: - Perform environmental monitoring of the aseptic manufacturing facility and ensure all testing aligns with the Environmental Monitoring programme. - Maintain QC facilities to meet GMP requirements and conduct necessary checks to support health authority visits. - Operate and maintain laboratory equipment, ensuring all equipment is calibrated and suitable for use. Requirements … Microbiology or equivalent relevant work experience in a regulated industry (i.e. pharmaceuticals, biologics, or medical devices). - Proficiency in Microsoft Office and knowledge of GMP/GLP regulations, FDA regulations, etc. - Strong problem-solving skills, analytical abilities, and a keen eye for aseptic behaviour. If you are interested in learning more »
This is a fantastic opportunity to work alongside our industry leading scientists in our GMP accredited laboratories, at our Sandwich facilities (Kent). You will gain a wide range of practical laboratory skills which are supported by our in-house training. Within the Analytical Sciences department in Sandwich, Kent we … of which used to support batch release, and regulatory packages. As such, you will be trained in all these techniques and general AMS and GMP procedures. There will also be a chance to undertake research for Solid Form Screening using some of the abovementioned methodologies. You will be trained to 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 »
on a WDA license as a Responsible Person or Responsible Person Import (RPi) Significant experience leading and developing a team GMP | GDP | GMDP | GoodManufacturingPractice | Good Distribution Practice | WDA | RP | Responsible Person | Head of Quality | Quality Director | Quality Manager | Wholesale Distribution License more »
opportunity to contribute to the advancement of cutting-edge T cell therapies for the treatment of serious medical conditions. Responsibilities: Batch Manufacturing within a GMP setting Support the scale up of Manufacturing operations in line with GMP standards Draft and maintain SOP’s and batch records Recording all activities and … Support and mentor more junior members of staff Qualifications: BSc or MSc degree in a Biological Science, Biotechnology, Immunology related field Experience in a GMPManufacturing environment Background in laboratory operations – Immunological cell-based assays Good understanding of and skilled with multi-parameter Flow Cytometry Work co-operatively as part more »
team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation activities for IT systems and … teams, and drive continuous improvement initiatives. *Key Responsibilities:* *Quality * * Lead and oversee the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. * Facilitate the effective management of deviations and CAPAs, ensuring regulatory compliance and continuous improvement. Additionally, you will play a pivotal role in … and approve changes to IT data processes, and documentation to ensure data integrity and compliance with regulatory requirements. * Manage IT projects, ensuring compliance with GMP guidelines, regulatory requirements, and industry standards * Stay informed about industry trends, regulatory changes, and best practices related to IT quality and GMP compliance *General IT more »
Compliance. Key responsibilities as our Technical & Quality Coordinator: Be a supportive member of the technical department by ensuring compliance with Food Safety, ACCP, Quality, GMP and H&S procedures. Develop and update technical documentation. Conduct internal audits, finished product traces, and support technical team during external audits. Collaborate with cross … Quality Coordinator: Food Technology/Science or equivalent degree Experience in a technical/quality role within food manufacturing Awareness, good understanding of HACCP, GMP, BRCGS standard and food legislation Be highly organised with the ability to work well under pressure and to tight deadlines Have competent IT skills and more »
Barnoldswick, Lancashire, North West, United Kingdom
Broughton Group
through both written and verbal channels are essential aspects of the role. Your ability to thrive in both regulated and agile environments, such as GMP and ISO 17025, will be crucial for success. Hours of Work: 40 hrs. Monday – Friday 8-hour days. 30 min lunch break. Development Scientist Requirements … user of standard ‘office' applications Desirable: Experience of method development/validation in a regulated environment Understanding of regulatory requirements such as ICH guidelines, GMP etc Able to troubleshoot problematic separations Experience with statistics packages E&L knowledge Development Scientist Benefits: Salary £27,820 - £40,660 Broughton Day Option of more »
build brighter futures for colleagues, clients and communities. The role will form part of the projects team with the current focus being around delivering GMP Equalisation projects on the proposition to clients, which can incorporate or lead onto being involved in de-risking projects for clients over time. This is … with internal teams to deliver a streamlined service to other lines of business. Directly involved with the management of more junior colleagues within the GMP Equalisation team, including supporting with performance reviews, training, and personal development plans. Develop skills to support on various consulting aspects of GMP projects and have … in Pensions, with a focus on Technical aspects and solid exposure to consultants and broader client support teams. Experience of technical calculations required for GMP Rectification and Equalisation projects. more »
Loughborough, England, United Kingdom Hybrid / WFH Options
ECS Resource Group
pharmaceutical environment/Medical Device industry required Technical experience within the Manufacturing functions of a pharmaceutical company. Technical knowledge of Pharmaceutical Packaging. Vendor Audits (GMP, Technical and EHS) Knowledge in Supply Chain Risk management, GMP, Quality System requirements, the ‘Orange Guide’, equivalent FDA regulations and systems, procedures, products and organisation. more »
responsibility will be to ensure that all materials are tested according to agreed specifications and procedures, in agreed time frames and in accordance to GMP and company guidelines. Other key responsibilities will include to: - Qualify, maintain and calibrate all laboratory equipment according to procedures. - Maintain all laboratory Quality Systems and … Assurance Performance Indicators. Your Background: You are required to have the following qualifications, skills and experience: - Knowledge of Quality Control, Quality Assurance, Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products. - Stability testing experience - Hands-on HPLC experience - Good technical and scientific judgement. - Diplomatic, self-motivating … professional with problem solving and decision-making capabilities. - Basic understanding of GMP Guidelines and Regulations. Apply: For more information, or to apply for this QC Analyst position please contact Hannah Oakley on 01246 457711 or email hoakley@ckgroup.co.uk. Please quote job reference 56706 in all correspondence. It is essential that more »
focus on compliance within a specific bakery, working with the teams to identify non-compliance and full engagement and support to ensure company processes. GMP and procedures are fully understood. Work with the bakeries to ensure compliance with relevant customer standards and codes of practice. Conduct physical factory audits (outside … safety and quality. Ensure that the Quality Management System internal audit schedule is completed, and all actions closed out in a timely manner. Ensure GMP & QA CCP audits are conducted to schedule and any non-conformances raised to bakery management. Verify that close out actions are robust and complete. Communicate more »
the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and GoodManufacturingPractice (GMP)./p br Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing more »
Job Description TechYard Recruitment is currently working with a global consultancy who are building a new GMP practice. They are hiring for a Programmatic Consultant. This person will be a programmatic subject matter expert. This is a client-facing role that will be responsible for several strategic initiatives across the … programmatic and GMP/GCP landscapes. These include collaboration on product strategy/vision, client-direct consultancy, license reselling, and internal and external training/education. This is a consultative role and the candidate will not be directly responsible for any media trading or activation. The ideal candidate will have … of channels, very strong analytical, and writing skills, and the ability to make clear, concise presentations. They will have extensive hands-on experience using GMP products and will be individually certified in the use of DV360 and other relevant GMP technologies. Most importantly, they must possess a strong inner drive more »
Glasgow, Lanarkshire, Scotland, United Kingdom Hybrid / WFH Options
Ernest Gordon Recruitment
Private Healthcare + Free Parking + Life Insurance + Pension + Ongoing Training + Progression Are you a Laboratory Manager with a background in GMP looking to join a company that is passionate about revolutionizing cancer therapy? You will take on a leadership role where you will receive full product … Your duties will encompass supervising production operations, resolving issues in cell culture processes, and spearheading quality investigations. Your meticulous oversight will ensure adherence to GMP standards and facilitate the seamless integration of novel procedures. This role would suit a Laboratory Manager with a background in GMP looking to join a … role where you will receive full product training, tremendous growth opportunities all while working hybrid. The Role: Manage T cell-based therapy production, maintaining GMP compliance. Lead production, troubleshoot processes, and conduct quality investigations. The Person: Life Sciences or related field background. Regulatory knowledge of T cell Therapy. Demonstrated leadership 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 »
