Junior Quality Assurance Analyst

Jobtailor; Linhares; Presencial; BRL 60 000 - 90 000; Tempo integral

Resumo da oferta

Jobtailor in Linhares, Brazil, is seeking a Quality Assurance professional to support the QMS, document control, and regulatory compliance. You will help manage deviations, CAPA, and change control while assisting health authority inspections.

The role requires a bachelor’s degree in a related field and knowledge of GMP, data integrity, and Good Documentation Practices. SAP and EQMS experience are advantageous, with a focus on quality excellence and continuous improvement.

Qualificações

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Production Engineering, Biomedicine, or related field.
• Experience in Quality Assurance, Quality Control, or QMS activities is desirable.
• Knowledge of GMP, data integrity, and Good Documentation Practices.
• Familiar with deviations, CAPA, Change Control, and training processes.

Responsabilidades

• Support maintenance of the Quality Management System (QMS) at the Linhares facility.
• Prepare, review, format, distribute, and control SOPs, work instructions, forms, specs, and other quality documents.
• Perform document and record control including issuing, distribution, and archiving obsolete versions.
• Assist in managing deviations, nonconformities, investigations, and CAPA activities.

Conhecimentos

QMS

Document Control

Deviations

Nonconformities

CAPA

Change Control

GDP

Data Integrity

QA Data Analysis

Regulatory Compliance

Formação académica

Bachelor’s degree (related field)

Ferramentas

SAP

Electronic Quality Management Systems

Microsoft Office

Descrição da oferta de emprego

• Support the maintenance, organization, and updating of the Quality Management System (QMS) at the Linhares facility.
• Prepare, review, format, distribute, and control SOPs, work instructions, forms, specifications, and other quality documents.
• Perform document and record control, including issuance, distribution, retrieval of obsolete versions, archiving, and monitoring review deadlines.
• Support the management of deviations and nonconformities, including recording, evidence collection, deadline tracking, and assistance with investigations.
• Support the management of corrective and preventive actions (CAPA).
• Support the Change Control process.
• Support the GMP and QMS training program.
• Assist in preparing and organizing documents and evidence for health authority inspections and audits.
• Monitor action plans resulting from audits and inspections.
• Support the qualification and monitoring of suppliers and service providers.
• Consolidate quality data and indicators, contributing to trend analyses and QMS meetings.
• Support activities related to quality complaints.
• Support quality risk management and continuous improvement activities.
• Verify compliance with GMP requirements and QMS procedures in the relevant areas, reporting deviations and improvement opportunities.
• Ensure that records under their responsibility are completed correctly, legibly, contemporaneously, and in a traceable manner, in accordance with data integrity principles.
• Keep up to date with internal procedures, GMP requirements, and applicable regulatory requirements.

Requirements

• Bachelor’s degree completed or nearing completion in Pharmacy, Chemistry, Chemical Engineering, Production Engineering, Biomedicine, or a related field.
• Previous experience in Quality Assurance, Quality Control, or QMS activities is desirable, preferably in the cosmetics, pharmaceutical, food, medical device, or chemical industries.
• Knowledge of Good Manufacturing Practices (GMP).
• Basic knowledge of Quality Management Systems and document control.
• Basic knowledge of deviations, nonconformities, CAPA, Change Control, and training processes.
• Knowledge of Good Documentation Practices and data integrity.
• Proficiency in Microsoft Office, especially Word and Excel.
• Preferred qualifications: experience in the cosmetics, pharmaceutical, or food industry; knowledge of RDC No. 48/2013, ISO 22716, and applicable cosmetic GMP requirements; experience with electronic quality management systems or ERP systems such as SAP; participation in audits or regulatory inspections.

Core Competencies

Demonstrates expertise in Quality Management Systems (QMS) and Good Manufacturing Practices (GMP), with a strong focus on document control, compliance, and quality assurance processes. Proficient in managing deviations, nonconformities, and corrective actions while supporting audits and regulatory inspections.

Highest-signal resume keywords

• Quality Management System (QMS)
• Good Manufacturing Practices (GMP)
• Document Control
• Corrective and Preventive Actions (CAPA)
• Quality Assurance Experience

Hard Skills

• Quality Management Systems
• Document Control
• Deviations Management
• Nonconformities Management
• Corrective and Preventive Actions (CAPA)
• Change Control
• Good Documentation Practices
• Data Integrity
• Quality Data Analysis
• Regulatory Compliance

Industry Keywords

• Pharmaceutical
• Cosmetics
• Food Industry
• ISO 22716
• RDC No. 48/2013

Tools & Technologies

• Microsoft Office
• SAP
• Electronic Quality Management Systems