Senior GCP QA Auditor

By joining us as a SeniorQA Auditor, you will support global investigations and CAPA processes at IQVIA. This will include Quality Issue investigations and Customer Audit/ Regulatory Inspection Responses, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure.

Your responsibilities will include:

• To lead global 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 closure 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.

• Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.

Qualifications:

Minimal requirements

• Bachelor’s Degree in Life Science or related field.

• At least 5 years experience in GCP Quality Assurance within pharmaceutical, technical, or related areas.

• Considerable knowledge of GCP, clinical trial, regulations and quality assurance auditing techniques.

• Fluent English language capabilities.

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.

• 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 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 – to help our customers create a healthier world.  https://

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $95,300.00 - $143,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.