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澳門 Macau, 澳門 Macau, 中国
Onsite
Provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage the quality assurance oversight of projects, assignments, training and staff. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Manage the investigations of quality issues, customer audits and regulatory inspections. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Establish and maintain relationships with internal customers such as Project Unit, Operational and Regional Heads and their management teams and external customer Quality Assurance (QA) functions. Act as line manager for one or more QA staff.
RESPONSIBILITIES
• Under the governance of IQVIA Global QA group, complete all trainings required by IQVIA Global QA, and be familiar with both IQVIA and Kun Tuo QA SOPs.
• Attend calls/meetings involving IQVIA Global QA or some of the Global QA team members
• Involve in both IQVIA and Kun Tuo QA activities as required.
• Plan, schedule, conduct, report, and close audit activities in any of the countries involved with IQVIA / Kun Tuo contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA/ Kun Tuo SOPs and project specific guidelines/instructions
• Oversee and host audits/inspections; Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements.
• Ensure implementation of Corporate Policies. • Represent QA on project related activities.
• Act as a resource on all aspects of GXP and related guidelines and regulations.
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Oversee and participate in the documentation, reporting, and closure of compliance issues.
• Organize and deliver training to other departments concerning the activities of Quality services, results of activities, quality initiatives, GXP etc. Oct 01, 2024
• Serve as Regional or Global QA Liaison for assigned customers, therapeutic groups and/or functional areas.
• Use the data available from Quality Assurance database (eQMS) to provide information, metrics and trend analysis to assigned project, operational and regional units on the quality of procedures, practices, projects and systems.
• Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
• Maintain an excellent knowledge of current GXP regulations, guidelines, and related auditing techniques appropriate to work responsibilities.
• Provide regular feedback to company Senior Management, on the above activities.
• Represent company at industry meetings, conferences, and seminars with presentations and training.
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Serve as author of Quality Assurance SOPs as required.
• Advise Quality Assurance management on system audit needs.
• Ensure the Quality Assurance database is maintained and up-to-date to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
• Act as line manager for one or more QA staff.
• Job requirements may necessitate business trips.
• Train new auditors and staff as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirement.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, team orientation, and leadership skills.
• Ability to work independently with initiative.
• Ability to manage multiple projects.
• Ability to manage staff
• Strong training capabilities.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s degree.
• 7 years’ experience in pharmaceutical, technical, or related area,including GCP Quality Assurance experience; Or a minimum of 3 years of QA relevant experience; 0-1 year of management experience; Equivalent combination of education, training and experience.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.