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 »
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 »
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 »
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 »
resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft Office, Internet Explorer and various business more »
risk assessments. Must be familiar with the operation and engineering aspects of plant and equipment for Pharma and/or Biotech facility, knowledge of GXP systems and practices, facility services and validation. The role holder will have considerable technical knowledge and high level of expertise of the job, strong mechanical 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 »
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 »
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 »
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 »
installation work 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 efficiency or 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 »
installation work and small projects.Provide support to other team members in accordance with experience and competencies.GeneralTo 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 efficiency or 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 »
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 »
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 »
exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.Key Responsibilities:To play a key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with emphasis on GCP compliance.To provide support and advice to Clinical Development teams with regards to … Definition of appropriate compliant procedures within GxP functionsManagement of quality issuesTo ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.To monitor the performance of GxP service providers with regards to the relevant quality standards.To define and manage clinical audit programme and to preform GCP audits 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 »
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 »
