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 »
play a pivotal role in connecting the business needs for designated process areas with requirements of both formal and informal learning in a regulated GxP environment. Connect with stakeholders of all levels of seniority to ensure a fully inclusive, sustainable learning solution is created to support the long term objective 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 »
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 »
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 »
play a pivotal role in connecting the business needs for designated process areas with requirements of both formal and informal learning in a regulated GxP environment. Connect with stakeholders of all levels of seniority to ensure a fully inclusive, sustainable learning solution is created to support the long term objective 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 »
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 »
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 »
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 »
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 »
play a pivotal role in connecting the business needs for designated process areas with requirements of both formal and informal learning in a regulated GxP environment. You will Connect with stakeholders of all levels of seniority to ensure a fully inclusive, sustainable learning solution is created to support the long 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 »
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 »
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 »
