Job Description

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:

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\xe2\x80\x99s Degree in Life Science or related field.

At least 3 yrs experience in pharmaceutical, technical, or related area including GCP and/or Quality Assurance experience.

Considerable knowledge of GCP 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.

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 \xe2\x80\x93 to help our customers create a healthier world. Learn more at

IQVIA