Senior QA Auditor - Pharma Compliance & Process Excellence

IQVIA; Singapore; Remote; 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

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.