QA Mgr

Job Description:

Responsibilities

•  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

Qualification & Experience

•  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..