Key Skills: C-Level Business and Administration Support, CXO support, GxP, Sox, Office, video collaboration and broadcast solutions Xcede are currently supporting a leading FMCG company who are undertaking multiple transformation programs and require a Support Analyst/Consultant who can be the conduit between CXO stakeholders and their admin … customer relationship management. * Good project and time management skills. * Excellent analytical skills. Preferred Qualifications * Excellent negotiation skills. * Experience working in a regulated environment e.g. GxP, Sox. Please note that C-Level support experience is mandatory, so if you offer the above skills then please provide a copy of your CV more »
Manage elements of the PQS pertaining to cellular therapies manufacture, including document control, risk management, training, and audits. Develop, review, and approve Quality and GxP-related documentation. Lead risk assessments and investigations as required. Approve equipment, materials, and services for site use. Conduct external audits as necessary. Provide strategic input … ATMP manufacture preferred. Demonstrated leadership of small QA teams. Proficient in providing scientifically sound, risk-based quality advice. Extensive experience in writing and reviewing GxP documents. Strong knowledge of GMP principles, sterile production, and regulatory requirements for cell therapy products. Experience in generating and utilizing quality metrics. Educational Requirements: University 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 »
Business Administrator for Veeva eQMS, oversee quality associated records and ensure these activities conform to regulatory requirements. Manage the controlled document scheme, act as GxP archivist, and deliver QA training activities. duties within Quality function. It is desirable, but not essential for the candidate to have a comprehension of basic … reports and dashboards in Veeva. Provide eQMS training to ensure competence across the business and maintain associated controlled documents. Ensure the appropriate storage of GxP documentation. Act as the primary company archivist by coordinating and preparing documentation for the offsite archive. Ensure appropriate process in place for the recall of … documents when requested. Administration of the quality assurance logs such as signature, notifications, QTA and audits. Document owner for GxP documents such as policies and the quality manual. Manage the controlled document scheme, including issuance and reconciliation. Provide information for Batch Record Review, QP certifications, Sponsor Release as and when more »
