IQVIA
life sciences
QAMgr
Neural analysis suggests this role is
optimal for Manager candidates.
“QA Mgr at IQVIA. Skills: Quality Assurance, Compliance, Audits. Plan audits. Schedule audits”
Industry & Context.
problem solving; risk analysis
What They're Looking For.
Must Have
5 years experience, 3 years in Quality Assurance, GXP experience, Knowledge of word-processing, Knowledge of spreadsheet, Knowledge of database applications, Knowledge of quality assurance processes, training capabilities, Effective organization skills, Effective communication skills, team orientation skills, Ability to initiate tasks, Ability to work independently, Ability to manage multiple projects, Ability to establish working relationships
Nice to Have
Bachelor's Degree Pref
What You'll Do.
Report audit findings
Close audit activities
Evaluate audit findings
Prepare audit reports
Distribute audit reports
Provide interpretation
Manage Quality Issues
Present educational programs
Review investigations
Approve investigations
Approve Root Cause Analysis
Approve Effectiveness Check plans
Provide quality assurance consultancy
Provide recommendations
Ensure proper conduct
Assist in regulatory inspections
Perform GLP Archivist duties
Manage quality events updates
Maintain electronic quality management system
Collaborate in QA initiatives
Support in QA initiatives
How You'll Work.
Team & Collaboration
operations staff; management; customers; project teams; clients; coworkers
Communication Scope
communication skills
Full Job Description
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
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