Qa Gcp Auditor 2 Jobs

By joining us as a QA Auditor 2, you will support Quality Issue investigations and 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:

• Present educational programs and provide guidance to operational staff on compliance procedures.
• Provide consultation to staff in interpretation of audit observations
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
• Evaluate audit findings and prepare and distribute responses to operations staff and management.
• Assist in training of new Quality Assurance staff.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• 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.
• Manage/oversee quality events updates in eQMS.
• 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.
• Manage Quality Issues and serious breach investigations.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Support in QA initiatives/projects for quality, process improvements.

Qualifications:

Minimal requirements

• Considerable knowledge of GCP regulations and quality assurance auditing techniques.
• Fluent language capabilities, including English.
• At least 3 yrs experience in pharmaceutical, technical, or related area including GCP and/or Quality Assurance experience.
• Bachelor’s Degree in Life Science or related field.

Skills

• 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
• Ability to work independently to problem-solve collaboratively and to raise issues appropriately as needed

What you can expect:

• Consistent career growth.
• Dynamic work environment that exposes you to new experiences.
• Leaders that support flexible work schedules.
• Attractive benefits package.
• Programs to help you build your therapeutic knowledge.

Work conditions

• Home based role.

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

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status