Senior QA Auditor

IQVIA; Singapore; Hybrid; SGD 60,000 - 90,000; Full time

Job summary

IQVIA Inc in Singapore seeks an experienced QA Auditor to plan and conduct independent audits, assess regulatory compliance, and prepare reports for stakeholders. The role requires interpreting regulations, guiding project teams, and promoting adherence to corporate policies.

You will evaluate findings, support corrective actions, train staff, and oversee QA initiatives across multiple projects, ensuring quality events are closed effectively within timelines.

Qualifications

• Bachelor's degree in a relevant specialization.
• Minimum 5 years' experience in Pharmaceutical or Medical Device QA in a highly regulated environment.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical R&D processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team player skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Responsibilities

• Plan, schedule, conduct, report and close audit activities to assess compliance with regulations, guidelines, and SOPs.
• Evaluate audit findings and prepare and distribute reports to staff, management, and customers.
• Provide interpretation and consultation on regulations, guidelines, compliance status, and policies.
• Advise customers and monitors on audit observations and corrective actions.
• Manage quality events and oversee QC processes.
• Present educational programs and guidance on compliance procedures.
• Review investigations, RCA, CAPA, and EC plans through to closure.
• Provide QA consultancy within budget and timelines.

Skills

Auditing

Regulatory knowledge

Quality assurance

Pharma industry

Interpersonal skills

Training skills

Documentation

Independent work

Education

Bachelor's degree in a relevant specialization

Tools

eQMS

Job description

Singapore

Full time

R1575157

Job Overview

Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

Essential Functions

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Manage Quality Issues
• Present educational programs and provide guidance to operational staff on compliance procedures
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Host audits/inspections, Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
• May perform GLP Archivist duties where needed
• Manage/oversee quality events updates in eQMS and/or Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new QA staff

Qualifications

• Bachelor's Degree in a relevant specialisation.
• 5 years' experience in Pharmaceutical or Pharmaceutical Manufacturing or Medical Device or Quality Assurance in a highly regulated environment.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team player skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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