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 »
a track record in Leading the HSE function across multiple companies in a Pharmaceutical environment. It is key that you have experience within a GXP/GMP environment. Purpose of the Job Health, Safety & Environment Lead and provide oversight and Global strategic leadership covering health, safety, and environment across the more »
issues. Work in close collaboration with Global Regulatory Leads and subject matter experts to ensure clinical trial deliverables are executed. Support internal and external GxP inspections. Leads project teams effectively to escalate and drive resolution of project issues. Effectively frames complex issues for decision-makers. Supports the Associate Director with more »
Worthing, England, United Kingdom Hybrid / WFH Options
Hobson Prior
in this location. Key Responsibilities: For this role, you will assist with compliance on all GMP/GDP and GCP regulations guaranteeing adherence to GxP and data integrity legislation. Serve as the System Owner/Administrator role for GxP IT systems that reside within QA. The ideal candidate will carry … data integrity documentation periodically and as needed. Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems. Collaborate with IT associates assuring suitable oversight of IT systems. Mediate with IT division associates linked to GxP impact and GxP compliance of … of pertinent change controls. Any other assigned duties. Requirements: Experience with TrackWise, LIMS and Documentum and/or any other QMS systems. Acquaintance global GxP, e.g., FDA CFRs, EU, 'Third countries' other than the UK. Familiarity within a pharmaceutical manufacturing, testing or quality assurance setting in a similar position. Prior more »
Senior GxP IT Compliance Specialist As the Senior GxP IT Compliance Specialist, you will lead compliance efforts for critical systems essential to GxP operations. Your role involves overseeing GxP IT systems from a quality assurance perspective, ensuring adherence to regulations and fostering a culture of data integrity. You'll serve … as the Data Integrity SME and contribute to maintaining and developing QMS related to IT. Key Responsibilities: Ensure ongoing compliance of GxP IT systems and processes. Support adherence to GMP/GDP and GCP regulations, including data integrity legislation. Act as System Owner/Administrator for GxP IT systems within … QA. Lead Computer System Validation and compliance processes. Review and lead compliance efforts for GxP IT system-related change controls. Provide coaching and support for data integrity adherence. Conduct periodic reviews of data integrity documentation. Assist in other quality systems as needed, such as Non-Conformances and CAPA. Collaborate with more »
Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
audits and contract auditors in line with the global audit plan, business model and applicable procedures · Plan, supervise, conduct, and support internal and external GxP audits · Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees · Maintain a tracking tool for audits … Quality System · Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective … training procedures in collaboration with other business companies and provide training in the area of expertise as assigned. 3. Inspections · Support the preparation for GxP inspections · Support the responses to Regulatory Authorities · Supervise and provide input to the corrective and preventive actions · Follow-up on the development, implementation and completion more »
Hoddesdon, Hertfordshire, South East, United Kingdom
PHARMARON UK LIMITED
formal qualification in core engineering discipline/secondary engineering discipline is desirable Broad based knowledge and interest in engineered systems and maintenance Understanding of GxP principals Knowledge of Temperature, humidity and pressure instrument loops, supporting BMS monitored HVAC, reactor systems, stability chambers/cold rooms and room pressure cascades. Experience … Engineering Workshop Supervisor to ensure all maintenance PM plans remain relevant, are technically correct and compliant. Ensure all documentation of maintenance activities are to GxP standards both in paper-based records and the Computer Maintenance Management System and that accurate reports are generated. Work on small projects where required, including more »
Milton Keynes, Buckinghamshire, United Kingdom Hybrid / WFH Options
S3 Science
in alignment with business objectives.Delivery of medium and large site Capital Projects within budget and timelineManagement of project execution resources and vendorsDeliver projects with GxP and Cybersecurity complianceOversee the coordination and management of project execution resources, including internal teams and external vendorsMaintain continuous engagement with all project stakeholders through regular … updates and strategic meetings to ensure alignment and address concernsJob Requirements:Experience in project management within the pharmaceutical or related industry, particularly with GxP complianceProven capability in managing both IT and OT domainsAbility to understand complex applications and OT asset landscapeIn-depth knowledge of Data Integrity, BMS, EMS, and SCADA more »
Brentford, Middlesex, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure more »
