Quality specialist 2

External Job description

Quality specialist 2

Primary Location: Mexico

IQVIA is looking for new talent as a Quality analyst responsible to support audit & Inspection readiness as part of the Functional Team. Including documental preparation, revision, reporting and resolution of PV monitoring exercises. Provision of advice and support on PV and quality topics to the team members to ensure compliance with worldwide PV requirements and expectations.

Progresses all elements of the nonconformance and CAPA process steps.

Works closely and provides guidance to functional team members with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems.

Responsibilities

• 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.
• 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Requires knowledge and understanding of global Pharmacovigilance regulatory requirements and industry best practices and an understanding of the principles of quality management, typically obtained through experience.

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

Bachelor's Degree: Science (physical, life, health) or Health Care profession (e.g., nursing or pharmacy)

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

Specific experience in quality for pharmacovigilance, compliance/auditing is desirable.

English Advanced

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above information on this description has been designed to indicate the general nature and level of work performed.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job.  While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time

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.