GCP QA CAPA Manager
GCP QA CAPA Manager
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$ 91100 - 151900
1 Vacancy
Job Description
By joining us as a QA CAPA Manager within Clinical Trials and GCP you willsupport 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. Preference is that candidate resides in EST zone.
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
- Bachelors 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 problemsolve collaboratively and to raise issues appropriately as needed.
- Good interpersonal communication and organizational skills to establish and maintain effective working relationships with coworkers 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.
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IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. potential base pay range for this role when annualized is $91100.00 $151900.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.
Required Experience:
Manager
Employment Type
Full-Time
