1 to 25 of 26 GxP Jobs

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 »

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 »

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 »

with a focus on FDA & EMA regulations Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA Bachelor s degree in a scientific discipline more »

Pharmaceutical production or development environment, to include QC and working with staff on issues arising within a production environment. Familiar with the concepts of GxP systems and other pharmaceutical terms and acronyms. Experience of managing Tech transfers, troubleshooting and product development of product change projects including process, analytical, planning, documentation 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 »

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 »

be beneficial to your application, but is not essential: Bachelors degree (or equivalent) in a scientific or technical discipline Worked within a pharmaceutical/GxP environment in a Quality related role Familiarity with the production of solid dose oral products Management of electronic & physical documentation systems Reward For the successful more »

awareness program (SETA) across all business functions. Manage external resources supporting the security awareness activities. Desirable Experience: Implementing controls and managing compliance risks regarding GXP regulated systems, data protection regulations such as EU and UK GDPR, CCPA, and cybersecurity regulations such as the EU NIS2 and USA SEC Disclosure Requirements. more »

procedures for the development lifecycle. Maintain in-depth knowledge of technical specialisms. Serve as a subject matter expert for architecture domain decisions. Comply with GxP requirements and standards using appropriate SOPs, methods, and tools. Perform additional duties as needed. Your Essential Criteria: BSc in Computer Science, IT, or related field more »

and Pharmaceutical Environment : Demonstrated several years of experience working with Computer System Validation (CSV) within a regulated pharmaceutical context, including adherence to Good Practice (GxP) standards. Expert Knowledge in CSV : Possess excellent knowledge and understanding of CSV principles and practices. Certification as a CSV expert is highly advantageous. In-depth more »

certification (advanced level) is required. ServiceNow Proficiency: Extensive hands-on experience with ServiceNow CMDB and related modules. Regulatory Knowledge: Familiarity with regulated environments (e.g., GxP, CSV) and related IT quality standards. Service Management Acumen: Comprehensive experience in defining and managing SLAs, KPIs, and contract-relevant service management issues. Communication Skills more »

to your application, but is not essential: HNC in Engineering or Construction (or equivalent). Previous experience within the pharmaceutical industry and working to GXP compliance. Experience using document control/maintenance management systems. Reward For the successful candidate, we offer an attractive benefits package which includes a competitive salary more »

Laboratory Information Management Systems, and are keen to develop their skills in an Information Technology environment. Knowledge of the different Pathology disciplines Knowledge of GxP regulations and system validation The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply. 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 »

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 »

services (e.g. PTQA or Scientific Training Programme) or working towards. Experience Essential Experience of pharmacy manufacturing or other significant experience of working in a GxP environment Quality control and quality assurance experience including environmental monitoring. Experience of working within and maintaining a Pharmaceutical Quality Management System - Change Control, Deviation and … implementing changes as appropriate. Desirable Experience of participation in external audit and hosting external auditors. Experience of line managing personnel Experience of conducting internal GxP quality assurance audits Experience of project management of complex systems Skills Essential Good organisational and time management skills. Able to work independently and show initiative … constructively and deal with issues sensitively. Skill of managing personnel within teams In depth and practical knowledge of the legislation and standards relating to GxP, ability to apply this knowledge to develop and maintain a Pharmaceutical Quality Management System. Knowledge of clean room design and function and HTMs/HBNs 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 »

We need someone who has experience working in a Pharma/life science environment who has good knowledge of working in a GMP/GxP environment. This is a strategic role and requires someone who has previous regional experience with some auditing experience. The role is based from home and … for leading the output from a team of QSHE people based in the region. Key responsibilities and activities Successful client and regulatory audits of GxP activities across the EMEA sites. Timely reporting and investigation of quality and safety related incidents and audits. Added value to the business through implementing efficient … working on other Global Pharmaceutical accounts. The group is responsible for conduct of audits, training, and quality/safety investigations, all of which ensure GxP and SHE regulations are satisfied. This position is home based, however travel is expected within EMEA to visit the relevant client sites. Essential Solid grounding more »

activities of the company in relation to QMS Compliance. To maintain awareness of existing and new legislation/guidance relating to EU and UK GXP for medicinal products and medical devices including all ISO activities relevant to medical devices including ISO 9001, ISO 13485 and ISO 14971; Controlled Drugs; Nutritional … Products; and General Data Protection Regulations and the UK Data Protection Act. What will you be doing? Maintaining Aspire Pharma Limiteds EU and UK GXP/ISO 9001/ISO 13485/ISO 14971 QMS, including: Staff training. Documentation control. Change control. Non-conformance/deviations. Validation. Corrective and/ more »

support in a team responsible for the delivery of the scientific and technical activities of the Immunoassay Group (IAG) and other groups within the GxP test facility when required. This post sits within the IAG Team. The successful candidate would be educated in degree level in a relevant subject area … of the application of serological assays to support clinical trials and/or product characterisation would be an advantage. Experience of working within a GXP environment is highly desirable. This post is not suitable for biomedical scientist accreditation. About us We pride ourselves as being an employer of choice, where 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 »

etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and … experience in eCTD, publishing, and the use of electronic portals Experience in management of CTAs including amendments and other CT-related submissions Experience in GxP compliance Experience in review of promotional and non-promotional material per the UK and Irish industry codes of practice would be advantageous Expert project management more »

etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and … experience in eCTD, publishing, and the use of electronic portals Experience in management of CTAs including amendments and other CT-related submissions Experience in GxP compliance Experience in review of promotional and non-promotional material per the UK and Irish industry codes of practice would be advantageous Expert project management more »