Quality Assurance Auditor

IQVIA; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

IQVIA, a global leader in clinical research services, is seeking a QA Auditor 2 to conduct and support audits, report preparation, and CAPA/EC activities across projects. The role includes hosting customer audits and inspections, interpreting regulations, and guiding project teams on compliance with SOPs and policies.

Ideal candidates have at least 4 years of QA or GXP auditing experience, strong problem-solving and communication skills, and the ability to manage multiple audits and initiatives

Qualifications

• Bachelor's degree preferred
• 4+ years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience
• Knowledge of word-processing, spreadsheet, and database applications
• Considerable knowledge of GXP regulations and quality assurance auditing techniques
• Strong interpersonal skills
• Excellent problem solving skills
• Effective organization, communication, and team orientation 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 in any countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, 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
• 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, RCA, CAPA and EC plans; track closures for quality events
• Present educational programs and provide guidance to operational staff on compliance procedures
• 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 for continuous process improvements
• Assist in training of new Quality Assurance staff
• Support in QA initiatives/projects for quality, process improvements
• Manage/oversee quality events updates in eQMS
• Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle

Education

Bachelor's Degree Pref

Job description

QA Auditor 2 Job Overview Conduct and/or support audits and report preparation/distribution, Support quality issues management, 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 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 Effectiveness Check (EC) plans. Track until closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
• Present educational programs and provide guidance to operational staff on compliance procedures.
• 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.
• 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
• 4+ 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..
• Strong interpersonal skills..
• Excellent problem solving skills..
• Effective organization, communication, and team orientation 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.

Experience Level Mid Level