Operations Specialist - Quality Assurance

Job Overview

Mainly responsible for the Product Quality Complaint (PQC) processes, including supply site liaising, case escalation resolution in compliance to applicable process and regulatory requirements. Supports process development, planning, management and execution of initiatives, identifying and raising insights, risk management and mitigation, and contributing to stakeholders training.

Essential Functions

• Conducts activities and interactions consistent with organizational values and behaviors and in compliance with the Code of Conduct and supporting policies and standards relevant to the role. Completes all required training on the Code of Conduct and supporting policies and standards within established timeframes. Reports potential issues of non-compliance.

• Supports projects execution, by following local procedural documents and local implementation of objectives, policies, processes and procedures and regulatory requirements, guidelines and obligations relevant to PQCs for medical devices and delivery systems (e.g. injectables, inhalers).

• Conducts a wide range of quality assurance activities of multifaceted scope and complexity on an individual basis working within established timeframes ensuring compliance with global and local procedures, policies, processes and guidelines.

• Supports the development, improvement and validation of procedures, policies, processes, guidelines, and/or systems for the product quality components of various activities and ensures they are compliant with AstraZeneca (AZ) standards, are aligned with targeted roles, and ensures non-compliant processes are escalated.

• Performs the tasks of PQC process to ensure consistent, clear, effective, and timely identification and communication of all PQCs to the appropriate investigation supply sites.

• Understands and supports the PQC related Global and Local regulations as well as processes of external customers.

• Support cross-functional communication by developing and maintaining appropriate and effective liaison relationships with functional areas and clients as required

• Works with the relevant stakeholders as appropriate, to create, update, and implement processes and procedures, including support on the creation, update and implementation of documents of reference such us but not limited to Customer Resource Documents (CRDs), Q&A, and FAQs

• Support document revision to ensure remains up-to-date with consistent, comprehensive and accurate content, and in alignment with Department and Clients policies, especially regarding PQCs.

• Responds to supply site inquiries regarding PQCs and follows up on supply site inquiries with customers as needed. Manages customer interactions to successful resolution. Obtains pertinent customer information and record customer interactions in appropriate systems. Meets quality and customer satisfaction standards.

• Supports, as needed, internal and external regulatory inspections of the PQC process

• Handles Drug Quality Reporting System PQC reports from the Regulatory Authorities, and third-party complaints, and enters them into QA and related systems

• Supports PQC investigation reports to third parties per Quality Agreement requirements

• Maintains a high level of understanding of relevant quality systems

• Remains current with evolving regulatory compliance and quality practices related to PQCs

• Supports the continuous processes and performance assessment, customer trends and issues, and program issues and risks. Champions the needs of customers by proactively contributing to the creation and implementation of improvements to processes and systems, and to mitigation of risk.

• Demonstrates the ability to present information to both internal and external stakeholders.

• Conducts and/or participates in training sessions in both classroom and individualized settings.

• Alerts project leaders of any suspected potential deficiencies in quality and compliance standards related to PQCs and works with the appropriate stakeholders to support alignment and implementation of corrective and preventative actions.

• Supports the preparation and conduction of Audits and inspections as applicable

• Trains and mentor other members of the team

Qualifications

• Bachelor's Degree Scientific or healthcare discipline or allied life sciences.

• English Level Advanced.

• 2 years of experience in pharmaceutical industry within Good Manufacturing Practices (GMP) quality assurance and best practices.

• Strong analytical skills and the ability to organize work in a logical, through and succinct manner. Excellent problem-solving skills.

• Knowledge of word-processing, spreadsheet, and database applications.

• Excellent verbal/written communication skills.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.