developments. Regulatory Intelligence: Maintaining awareness of existing and new legislation/guidance relating to ensuring developments comply with GMP/GDP/GCP and GXP, HMR, MDD and MDR where applicable. Quality Policy: To maintain an awareness of, and compliance with the company Quality policy and objectives, and applicable internal more »
Ensure GMP, Data Integrity, and GDP compliance, including timely training. Key Competencies: Proven track record in delivering regulatory-compliant validation strategies. Strong understanding of GxP compliance requirements. Excellent communication and issue escalation skills. Flexibility to adapt to business needs and experience with complex projects Proficiency in project planning software is more »
Uxbridge, England, United Kingdom Hybrid / WFH Options
ISR Recruitment
in a fast-paced, agile-working environment Significant experience focusing on commercial country and product launches and being accountable Experience in the delivery of GxP projects and systems as several platforms will require GxP related changes and will be subject to Computer System Validation (CSV) Please call Edward Laing here more »
PMDA and other global regulatory agencies. Who We Are Zigzag Associates partners with companies across the entire drug discovery and development process to improve GxP Quality against global regulatory standards. We are a global, certified woman owned company who put people first and forge lasting relationships to bring deep impact more »
leading continuous improvement of quality and regulatory systems. The role will support and ensure that the 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 … tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders. Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans. Working with the wider site functions to … procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance. Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken. Support quality related investigations, assist in the development and approval more »
conduct site visits to ensure project completion and right first time quality is driven. Work with internal team members cross-functionally Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for New Product Development/Post Launch/lifecycle management activities. Act more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
do business. The Opportunity Dechra Pharmaceuticals are looking for an experienced auditing professional to join our manufacturing division on a remote basis. Support the GxP and Regulatory compliance of Dechra Products by developing audit systems which will ensure process and product compliance with applicable GMPs/GDPs throughout the product … lifecycle. Develop, approve, and monitor the risk based GxP audit programme and budget for Dechra DPMS. Develop and support inspection readiness at Dechra Internal Manufacturing sites, sustaining their ability to successfully conclude regulatory inspections for Dechra's products. Provide US and European regulatory intelligence, train Subject Matter Experts and provide … and review or preparation of responses to deficiencies) and on-site presence as required. Develop audit systems to ensure key elements of the Dechra GxP Quality Management System and the requirements of the product licences/marketing authorisations are effectively implemented throughout the internal and external manufacturing network (as required more »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
re particularly keen to hear from those who have/are: Extensive Pharmaceutical Industry with hands on experience in development/quality in a GxP environment. Proven track record of implementing phase appropriate quality strategies Direct experience proving quality oversight of CDMOs Excellent working knowledge of FDA and EU GMPs more »
as indicated in applicable controlled documents, are followed Perform other duties, as assigned by management Minimum Required: 8 years in regulatory environment (experience in GXP roles) Experience & regulatory expertise of industry quality systems/standards Ability to interpret applicable regulations/standards Experience in leading process improvement initiatives Ability to more »
techniques such as UV, HPLC, FTIR Will be able to demonstrate previous effective experience in a similar environment Prior experience working in a regulated GxP environment This is a fantastic opportunity for an experienced Analytical Chemist to work with a highly successful global company based in Central Belt of Scotland. more »
business users, establish and maintain a positive professional relationship with users and clients Participate in testing, documentation and implementation of assigned projects Execution of GxP-related activities in adherence to standard operating procedures Additional duties as and when required, travel to other sites as required Essential Skills: Desktop operation and more »
business users, establish and maintain a positive professional relationship with users and clients Participate in testing, documentation and implementation of assigned projects Execution of GxP-related activities in adherence to standard operating procedures Additional duties as and when required, travel to other sites as required Essential Skills: Desktop operation and more »
Manage, coach and mentor more junior members of staff. Provide clear scientific and technological leadership to direct reports. Comply with all relevant safety and GxP procedures. Plan and prioritise own, and team’s work with input from senior manager when required. Involve in CRO’s selection process. Provide an oversight more »
heavily focused on quality, and experience in the pharmaceutical or medical industry is highly desirable. Key Responsibilities: Ensure successful client and regulatory audits of GxP activities across EMEA sites. Report and investigate quality and safety-related incidents and audits in a timely manner. Implement efficient, standardised systems and processes. Perform … Belgium, Switzerland, or Netherlands. Experience: Solid background in a quality or HSE role within the pharmaceutical or life sciences environment. Familiarity with a regulated GxP environment is essential. Qualifications: EU Quality or HSE qualification. ISO Lead Auditor qualification is desirable. Skills: Excellent communication, influencing, and facilitation skills. Ability to work more »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
other managers and staff and provide training, tools and techniques to enable others to achieve quality standard. Key Skills and Requirements: Significant understanding within GxP operational and quality roles. Operational experience in at least one of the following areas: Biostats, Data management, Clinical Trial Supply and Logistics, IRT, Pre-clinical more »
IT software development lifecycles, with commercial experience of agile methodologies Experience with the implementation and maintenance of Salesforce applications and their delivery in a GxP environment working with dispersed and global teams Experienced in managing the delivery and performance of third-party vendors (primarily off-shore) with the ability to more »
serialization of medicines. - Proven project management experience. - Excellent problem-solving skills and attention to detail. - Experience working with databases and computer systems. - Familiarity with GxP environment, experience of Computer Systems Validation is a plus. - Excellent communication skills, proficient in written and spoken English. If you are having difficulty in applying more »
ELISA analytical systems as well as the ability to develop and validate analytical methods using ELISA. • The ability to document laboratory information to a GXP standard and perform quality control processes. Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56600 in more »
and contribute to regular staff and management meetings, as necessary. Requirements: A degree or equivalent in a relevant scientific discipline A background in a GxP environment is required Previous project management experience from the life science industry is essential Knowledge of Project Management Processes and excellent client facing skills A more »
serialisation of medicines Problem solver who can work through complex issues. Experience of working with databases and computer systems Experience of working in a GxP environment, experience of Computer Systems Validation We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of more »
solver who can work through complex issues • Good attention to detail • Experience of working with databases and computer systems • Experience of working in a GxP environment, experience of Computer Systems Validation Interested? Apply now for immediate consideration or contact Elias Adem on eadem@planet-pharma.co.uk We are an equal opportunities more »
validating computer systems in a Biopharmaceutical setting. A Degree (or equivalent experience) in a Science or related discipline . Experience in the validation of GxP software and Laboratory systems. Prior ERP integration experience would be advantageous, but not essential. more »
join the Digital Organization reporting to the Director of Digital Lab Systems. The engineer will be responsible for implementing and supporting IT systems in GXP Lab and Manufacturing sites. The Engineer will collaborate with the digital team to develop effective approach to integrate IT architecture into the labs. The Engineer … with automation engineers, plant engineers, lab engineers, scientists, and operations teams to design, develop, and support the lab IT systems. As this is a GXP environment, the candidate must be familiar with the GXP process and the IQ/OQ/PQ Validation process for IT systems. In addition, the … IR35 contract and is onsite 5x a week Must Haves: Proven experience working in IT Infrastructure in manufacturing and lab systems Familiar with the GXP process and the IQ/OQ/PQ Validation process for IT systems. Experience with implementing IT Applications and troubleshooting IT applications Degree in Computer more »
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 more »
Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications. The role will support the 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 … documentation according to internal guidelines and UK/EU/US/ICH and other region specific guidance. •Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken. •Support quality related investigations, assist in the development and approval more »
