Operations Specialist - Quality

Job Overview

Primarily responsible to ensure audit & Inspection readiness as part of the Functional Team, including non-conformance and CAPA handling, scheduling, planning, reporting and resolution of MI/PV  monitoring exercises. Ensures alignment with quality assurance (QA) policies and procedures wherever possible and leading the functional implementation of the MI/PV QA quality system for the projects under scope. Provision of advice and support on MI/PV and quality topics to the team members to ensure compliance with worldwide MI/PV requirements and expectations.

Essential Functions

• Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and Project and Department policies and procedures by continuous evaluation of MI/PV processes through audit and QA oversight activities.

• Contributes to the delivery of innovative quality strategies and solutions through collaboration with business partners and other QA functions to support effective and timely solutions to compliance issues and/or questions.

• Contributes to development and continuous improvement of necessary MI/PV systems to assure compliance to worldwide regulations and corporate policies.

• Advances the Project Quality System through contribution to the development and implementation of systems and processes required to support local/regional and global quality assurance requirements.

• Contributes to the MI/PV audit/inspection readiness program by planning and, executing internal MI/PV monitoring exercised and working with the internal team to resolve any non-compliance identified.

• Actively participates in and supports MI/PV audits and inspections onsite or remotely to ensure successful results and support resolution of findings by working with the functional MI/PV team members.

• Promotes continuous education with regards to MI/PV regulations and expectations for self and other Project and Department staff.

• Participates in the analysis of MI/PV compliance data and emerging regulatory intelligence to demonstrate appropriate QA supervision of the compliance of the Project and Department MI/PV systems. Evaluates and progress the timely completion of CAPA system activities, including initiation, investigation, corrections, corrective and preventive actions, and effectiveness checks.

• Manages timelines, sets milestones, and manages the timely competition of all activities related to non-conformances, potential non-conformances, and/or deviations.

• Drive the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the non-conformance.

• Facilitate cross functional problem solving by using root cause analysis tools such as fishbone diagram, process flow charts, interviews, is/is not.

• Ensure accurate CAPA reports writing and documental evidence integration is complete, clear, and concise.

• Conduct data analysis on department metrics, compile management review slides, compiles post market surveillance slides.

• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.

• Ensures maintains the effectiveness of the quality records to ensure audit-readiness for internal and external quality system audits within the area.

• Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and Project and Department policies and procedures by continuous evaluation of MI/PV processes through audit and QA oversight activities.

• Contributes to the delivery of innovative quality strategies and solutions through collaboration with business partners and other QA functions to support effective and timely solutions to compliance issues and/or questions.

• Contributes to development and continuous improvement of necessary MI/PV systems to assure compliance to worldwide regulations and corporate policies.

• Advances the Project Quality System through contribution to the development and implementation of systems and processes required to support local/regional and global quality assurance requirements.

• Contributes to the MI/PV audit/inspection readiness program by planning and, executing internal MI/PV monitoring exercised and working with the internal team to resolve any non-compliance identified.

• Actively participates in and supports MI/PV audits and inspections onsite or remotely to ensure successful results and support resolution of findings by working with the functional MI/PV team members.

• Promotes continuous education with regards to MI/PV regulations and expectations for self and other Project and Department staff.

• Participates in the analysis of MI/PV compliance data and emerging regulatory intelligence to demonstrate appropriate QA supervision of the compliance of the Project and Department MI/PV systems. Evaluates and progress the timely completion of CAPA system activities, including initiation, investigation, corrections, corrective and preventive actions, and effectiveness checks.

• Manages timelines, sets milestones, and manages the timely competition of all activities related to non-conformances, potential non-conformances, and/or deviations.

• Drive the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the non-conformance.

• Facilitate cross functional problem solving by using root cause analysis tools such as fishbone diagram, process flow charts, interviews, is/is not.

• Ensure accurate CAPA reports writing and documental evidence integration is complete, clear, and concise.

• Conduct data analysis on department metrics, compile management review slides, compiles post market surveillance slides.

• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.

• Ensures maintains the effectiveness of the quality records to ensure audit-readiness for internal and external quality system audits within the area.

• Trains and mentor other members of the team.

Qualifications

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

• 4 years of experience in pharmaceutical industry within quality assurance including audit preparation and conduction.

• English Level Advanced.

• Requires knowledge and thorough understanding of global Pharmacovigilance regulatory requirements and industry best practices and an understanding of the principles of quality management.

• 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.