QA Auditor (clinical Data Management)
Quintiles
6 - 8 yrs
Bengaluru/Bangalore
Job Description
- PURPOSE
Plan, conduct, and report assigned quality assurance audits. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Provide quality assurance oversight under the direction of senior QA staff through interaction with customers, project and study teams and associated Quintiles functions.
RESPONSIBILITIES
Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Quintiles contracts to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
Conduct quality assurance activities and projects for clients according to Quintiles departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.
Assist in preparation and review of corrective action plans.
Represent quality assurance program on customer and project teams under the direction of more senior QA staff.
Document and report quality and compliance issues to QA management according to required timelines.
Advise quality assurance management on system audit needs.
Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed. May host some customer audits independently as directed by QA line management.
Assist in preparation and review of corrective action plans associated with customer audits
Enhance and maintain a working knowledge of relevant GXP regulations
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
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.
Company Profile:
Quintiles
Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health รข„¢. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.
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