Gcp Qa Auditor 2

Job Overview:
Provide Quality Assurance support and independently manage assigned Quality Events in accordance with the IQVIA Process/System requirement. 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:

• Review, approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for medium/high-risk/complex quality events arising from Quality Issues, Audits, Inspections or during similar QA activities

• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements

• Provide consultation to internal stakeholders in interpretation of audit/inspection observations and formulation of corrective action plans

• Assist in training/Onboarding of new Quality Assurance staff

• Provide guidance to operational staff on compliance procedures when required

• Manage/oversee quality events updates in eQMS and/or Maintains the electronic quality management system (eQMS) and provides support in relation to the Quality Events lifecycle

• Lead/collaborate/support in QA initiatives/projects for quality, process improvements/departmental goals

Qualifications:

• Bachelor's Degree Pref

• 5+ years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GCP and/or GVP experience. Equivalent combination of education, training and experience.

• Knowledge of word-processing, spreadsheet, and database applications..

• Extensive knowledge of pharmaceutical research and development 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 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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $70,900.00 - $106,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.