Quality Assurance Auditor 2

Job Role: -QA Auditor 2

Experience: 3-6 Years

Location: Mumbai

Work Mode: Hybrid - Candidate visit IQVIA Lab, Mumbai as required. Weekly expectations will be set

(approx. twice a week)

Must have skills: Internal audits and hosting external audits

- Deviation review/Non Compliance review

- CAPA review /CAPA evidence approval

- GXP experience

- Quality assurance auditing techniques

- GCP background

Summary:

Customer Audit/ Regulatory Inspections hosting, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements

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, Standard Operating Procedures ( 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

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policies and procedures.

• Provide consultation to customers and monitors in interpretation of audit observations
• 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 Quality Issues
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and
• Assist in training of new Quality Assurance staff.
• Support in QA initiatives/projects for quality, process improvements
• Manage/oversee quality events updates in eQMS
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle

Qualifications

• Bachelor's Degree Pref
• 3 years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience. Pref • Knowledge of word-processing, spreadsheet, and database applications..
• Considerable knowledge of GXP regulations and quality assurance auditing techniques.