QA Auditor 2
Location: Thāne, India
Job Type: Full Time
Job ID: R1462657
Job Description
As a QA Auditor 2, you will play a vital role in executing and supporting internal and external audits, quality issue management, CAPA planning, and ensuring regulatory compliance. This role involves providing quality assurance consultancy, hosting audits/inspections, and collaborating with stakeholders to enhance quality systems and maintain operational excellence.
Key Responsibilities
Audit Management:
Plan, schedule, conduct, report, and close audits across IQVIA-contracted countries.
Evaluate findings and distribute reports to relevant internal teams and clients.
Perform GLP Archivist duties where necessary.
Compliance and Consultation:
Provide expert interpretation of regulatory guidelines, SOPs, and project-specific protocols.
Advise project teams, customers, and monitors on audit observations and compliance issues.
Audit Hosting and Inspections:
Host customer audits, mock inspections, and assist in regulatory facility inspections.
Quality Issue Management:
Oversee investigation reviews, Root Cause Analysis (RCA), CAPA and Effectiveness Check (EC) plan approvals and closures.
Track quality events from audits, inspections, or similar QA activities.
Training and Education:
Present compliance training sessions to operational staff.
Assist in onboarding and training of new QA team members.
Process Improvements:
Evaluate and recommend improvements in policies and procedures to align with regulatory standards.
Support initiatives/projects to drive quality and process optimization.
eQMS Oversight:
Maintain and update the electronic Quality Management System (eQMS) related to audit lifecycle activities.
Qualifications
Education: Bachelor's Degree (preferred).
Experience: Minimum 3 years in pharmaceutical, technical, or related sectors with GXP and/or QA experience (or an equivalent combination of education, training, and experience).
Skills:
Strong knowledge of GXP regulations and quality auditing techniques.
Proficient in word-processing, spreadsheet, and database tools.
Excellent problem-solving, communication, and interpersonal skills.
Well-organized with the ability to manage multiple projects independently.
Effective team collaboration and relationship-building capabilities.
About IQVIA
IQVIA is a global leader in clinical research, healthcare data analytics, and pharmaceutical services. Our intelligent connections drive innovation in healthcare, advancing medical progress and improving patient outcomes worldwide. Learn more at IQVIA Careers.
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