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 »
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 »
Outlook • High attention to detail, strong organisational skills and ability to multitask. Keywords: Planner, service, equipment, coordinator, administrator, administration, planning, scheduler, CMMS, GMP. GLP, GXP, GDP, Good Laboratory Practice, Good Manufacturing Practice, Good Documentation Practices, Manchester, Northwest, Macclesfield. VRS8731MP. Follow VRS Recruitment on LinkedIn to view all our latest vacancies 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 »
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 »
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 »
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 »
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 »
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 »
Linton, England, United Kingdom Hybrid / WFH Options
Owlstone Medical
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 »
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 »
london (uxbridge), south east england, United Kingdom
Cognizant
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 »
Oxford, England, United Kingdom Hybrid / WFH Options
Jazz Pharmaceuticals
supporting and improving business capabilities for Quality Systems within a regulated pharmaceutical environment . This role includes system ownership and service management for key GxP applications, such as Veeva Quality Vault (Document and Quality Management) and JazzLearn (the primary learning management system supporting GxP training). Essential Functions/Responsibilities … validation test protocols, such as IQ/OQ/PQ Collaborate with other System Owners, Jazz Digital QA and IS Compliance to ensure that GxP systems are operating as expected and are maintained in accordance with regulatory requirements and Jazz SOPs Work with IS Business Partners, Business Process Owners and … for a pharmaceutical company. Knowledge of Veeva Systems (advantageous) Knowledge of Learning Management Systems (particularly in the Pharma industry) Experience as System Owner for GxP systems Maintains knowledge of cGxP, IS Compliance, IS Security, SOX, data privacy & integrity, and other risk management considerations, and ensures they are embedded in projects 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 »
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 »
these in the absence of the Head of Quality. Represent QA on any risk assessment activities relating to GCP/clinical trials Complete all GXP training relevant for the role Working with the Head of Quality to ensure we are ‘Inspection Ready’, this includes the building of the GCP Inspection 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 »
london (uxbridge), south east england, United Kingdom
ISR Recruitment
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 »
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 »
as part of a multi-disciplinary team. Key Skills and Requirements: - Experience working within a Pharmaceutical/Medical Device Quality Assurance department. - Knowledge of GxP and Quality related regulations and standards within the Pharmaceutical/Medical Device industry. - Familiarity with ISO 9001, ISO 13485, GCP is essential. - Knowledge of ISO 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 »
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 »
projects. Provide support to other team members in accordance with experience and competencies General tasks: 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 »
