QA Capa Manager

MTV; Buenos Aires; Presencial; ARS 72.429.000 - 101.401.000; Jornada completa

Descripción de la vacante

A global healthcare company in Buenos Aires is seeking a QA CAPA Manager to lead global investigations in compliance with regulations. The role requires a Bachelor's Degree and at least 5 years of experience in GCP Quality Assurance. You will oversee quality events, evaluate audit findings, and provide support in CAPA processes. Candidates should possess strong problem-solving skills and be fluent in English. The position offers career growth and flexible work options as part of an attractive benefits package.

Servicios

Consistent career growth

Flexible work schedules

Attractive benefits package

Formación

• 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.

Responsabilidades

• Lead global investigations and support teams with CAPA preparation.
• Evaluate audit findings and prepare responses to operations staff.
• Provide consultation to staff in interpretation of audit observations.
• Manage Quality Issues and serious breach investigations.
• Review, approve investigations, RCA, CAPA and EC plans.

Conocimientos

Ability to work independently

Good interpersonal communication

Organizational skills

Educación

Bachelor’s Degree in Life Science or related field

Descripción del empleo

QA CAPA Manager

By joining us as a QA CAPA Manager,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.

Responsibilities

• 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.

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.