QA Senior Auditor | CAPA Management | LATAM page is loaded QA Senior Auditor | CAPA Management | LATAM Apply locations Buenos Aires, Argentina Mexico City, Mexico Santiago, Chile São Paulo, Brazil Bogota, Colombia time type Full time posted on Posted 4 Days Ago job requisition id R1352097 The Quality Assurance team is aiming to lead investigations and support CAPA from LATAM inspections and Customer audits in LATAM offices or sites.
By joining us as a QA Senior Auditor, you will support Quality Issues in key accounts that have project leadership located in Western time zones in order to support investigation meetings more effectively by performing Customer Audit/ Regulatory Inspections report responses, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development.
Your responsibilities will include:
To perform investigations and support teams with CAPA preparation in compliance with applicable... regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.
Evaluate audit findings and prepare and distribute responses to operations staff and management.
Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
Provide consultation to staff in interpretation of audit observations
Manage Quality Issues and serious breach investigations.
Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
Present educational programs and provide guidance to operational staff on compliance procedures.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Assist in training of new Quality Assurance staff.
Support in QA initiatives/projects for quality, process improvements.
Manage/oversee quality events updates in eQMS.
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
Qualifications:
Minimal requirements
Bachelor's Degree in Life Science or related field.
At least 3 yrs experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience.
Considerable knowledge of GXP regulations and quality assurance auditing techniques.
Fluent language capabilities, including English.
Skills
Ability to work independently to problem-solve collaboratively and to raise issues appropriately as needed
Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors.
Good technology word processing, spreadsheets and database applications skills and knowledge of MS Office applications
What you can expect:
Consistent career growth.
Leaders that support flexible work schedules.
Programs to help you build your therapeutic knowledge.
Dynamic work environment that exposes you to new experiences.
Attractive benefits package.
Work conditions
• Home based role.
• Grade 140 (Sr. Role)
Please apply with your English CV.
#LI-Remote #LI-RUBENALEJOS
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
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To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us
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