Auditeur QA senior - Technologie, Sr QA Auditor - Technology

Location: Kirkland

Job Description

Homebased - Canada

Job Overview
Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

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, IQVIA 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 and formulation of corrective action plans

Manage Quality Issues

Present educational programs and provide guidance to operational staff on compliance procedures

Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during simillar QA activities

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

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

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

Assist in training of new Quality Assurance staff

Qualifications

Bachelor's Degree Pref

5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GXP 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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request.

La fourchette salariale de base potentielle pour ce poste, annualisée, est de $84,000.00 - $. Le salaire de base réel offert peut varier selon plusieurs facteurs, notamment les qualifications liées à l’emploi telles que les connaissances, les compétences, la formation et l’expérience; l’emplacement; et/ou l’horaire (temps plein ou temps partiel). Selon le poste offert, des régimes d’incitation, des primes et/ou d’autres formes de rémunération peuvent être proposés, en plus d’une gamme d’avantages sociaux liés à la santé, au bien-être et/ou d’autres bénéfices.

The potential base pay range for this role, when annualized, is $84,000.00 - $. 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 wellness and/or other benefits.

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