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 »
City Of London, England, United Kingdom Hybrid / WFH Options
i-Pharm Consulting
Delivery Consultant - GxP/MSP London - Liverpool Street £28K - £32K + Commission per placement i-Pharm Consulting is looking to hire a Delivery Consultant with a background in resourcing or delivery for key accounts. The Delivery Consultant will work within our GxP/Delivery Team sourcing Life Sciences professionals for 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 »
RC&QA Leadership Team's delegate Perform other duties, as assigned by management Required profile: Required experience: 10+ years in regulatory environment (experience in GXP roles) Experience & regulatory expertise of industry quality systems/standards Ability to effectively communicate functional strategy with external parties Ability to effectively lead teams through 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 »
management, serverless computing, microservices architecture, etc.) Proven experience with Agile/Scrum methodologies Proven experience with a B2B SaaS Start-up Proven experience with GxP industry and Computer System Validation Strong problem-solving skills and ability to work effectively in a collaborative team environment Excellent communication skills and ability to more »
audits) Experience/Knowledge Suitable working knowledge within a Pharmaceutical/Medical Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external more »
as the RC&QA Leadership Team's delegate Perform other duties, as assigned by management Required experience: 10+ years in regulatory environment (experience in GXP roles) Experience & regulatory expertise of industry quality systems/standards Ability to effectively communicate functional strategy with external parties Ability to effectively lead teams through more »
and small projects. Provide support to other team members in accordance with experience and competencies. To ensure documentation required for statutory, H&S and GxP standards are completed and filed. Arrange contractor site inductions and enabling work to start safely. Propose ideas/initiatives for continuous Improvement to streamline, increase more »
be a part of these roles. Good understanding/knowledge of software engineering (should come with above) Designing strategy and setting strategy Knowledge of GxP procedures and familiarity with ISO9001/ISO27001 Technologies they use: Frontend, React or python. Backend is Golang. If you're interested in working for a more »
Quality Business Analyst BA in charge of being the link with business stakeholders and the Quality/BA Team. Experience as a BA - circa 5+ years to work independently. Experience with Veeva and other quality systems. Must understand GXP. Order more »
Manchester Area, United Kingdom Hybrid / WFH Options
Factorytalk
platform for Pharmaceutical and Biotech customers. This is groundbreaking work, reinventing the MES concept. So, as well as knowledge and experience of MES and GxP IT projects, you absolutely must be open to working in new ways with a flexible and creative mindset in tight collaborative teams with colleagues and … customers. Factorytalk has unique experience and know-how in creating, building, and validating GxP Apps using this modern digitalization tool. You will receive extensive training on Tulip, attain certification, and additional training on Factorytalk’s specialist App design, building, and validation methods to deliver Tulip solutions for GxP use. This more »
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 »
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 »
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 »
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 »
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 »
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 »