Job Title: QA Auditor 2
Location: Thāne, India
Job ID: R1462657
Job Type: Full-time
Job Available in Additional Locations
Job Overview:
As a QA Auditor 2 at IQVIA, you will be responsible for planning and conducting audits, managing quality issues, supporting regulatory inspections, and ensuring compliance with GxP regulations. You will play a key role in quality assurance initiatives and act as a consultant for internal and external stakeholders, ensuring adherence to corporate policies, regulatory requirements, and continuous quality improvements.
Essential Functions:
Plan, schedule, conduct, report, and close audits across multiple countries, ensuring compliance with applicable regulations, customer requirements, SOPs, and project guidelines.
Evaluate audit findings and generate detailed reports for operations, management, and clients.
Offer expert interpretation and consultation on regulations, compliance status, policies, and procedures.
Provide guidance to customers and monitors on audit observations and findings.
Host and support customer audits, mock regulatory inspections, and actual regulatory inspections.
May perform GLP archivist duties as required.
Oversee quality issue management including:
Review and approval of investigations and root cause analyses (RCAs).
Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans.
Tracking of quality events until resolution.
Deliver training and educational programs on compliance and QA practices.
Conduct quality assurance consultancy for clients within defined budgets and timelines.
Assess internal policies and recommend process improvements.
Support training of new QA staff and participate in quality/process improvement initiatives.
Maintain and manage updates in the electronic Quality Management System (eQMS), including audit lifecycle documentation.
Qualifications:
Education: Bachelor's Degree (Preferred).
Experience:
Minimum 3 years of experience in pharmaceutical, technical, GXP, or Quality Assurance domains.
Equivalent combinations of education, training, and experience may be considered.
Technical Skills:
Proficient in Microsoft Word, Excel, and database applications.
Strong understanding of GXP regulations and auditing techniques.
Core Competencies:
Excellent interpersonal and problem-solving skills.
Strong organizational, communication, and teamwork abilities.
Ability to initiate and manage tasks independently and handle multiple projects simultaneously.
Strong client and stakeholder relationship management skills.
About IQVIA:
IQVIA is a global leader in healthcare intelligence, clinical research, and advanced analytics. We connect data, technology, and science to drive better healthcare solutions and accelerate the development of life-changing therapies. Learn more at IQVIA Careers.
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