職位描述
RESPONSIBILITIES:The Quality Assurance GxP accountabilities are split between the QA teams as below:· * Audit team - GCP, GVP, GRP, LabGCP including strategy where applicable * LabsQA team - GLP, HBS, GLS, LabGCP, ISO 17025, CLIA including strategyAudit * Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits. * Participate in and may lead directed (For Cause) audits. * Works with contract personnel or consultants to prepare, conduct and report outsourced audits * Supports Due Diligence activities as assigned * Leads Supplier qualification activities (Operational Due diligence ODD) as assigned * Identify and assess gaps during supplier qualification assessmentsCAPA * Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completionInspection * Provides QA oversight and/or management of regulatory GxP inspections * Collaborates with Quality Assurance lead, to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.General Accountabilities * Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines * Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits * Communicates effectively with QA colleagues and business stakeholders * Maintains knowledge of relevant industry information affecting quality and compliance arena * Leads training for colleagues and business stakeholders as required. * Involved in and may lead the development and/or revision of QA processes, projects and tools * Provides general support related to regulatory authority inspections as and when required * Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expert * Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations * Travel expectedREQUIRMENTS: * Degree level education or equivalent experience * Experience in pharmaceuticals or a related industry * Excellent analytical, written and oral communications skills * Fluent in written and spoken English * High ethical standards, trustworthy, operating with absolute discretion * Strong collaborative, influencing and interpersonal * skills – curious to understand business environment * Skilled at managing & using technology * Ability to maintain and create professional networks with stakeholders * Supplier qualification
