Senior GMP Analyst – Quality Assurance

Job not on LinkedIn

🔥 1 hour ago

🇧🇷 Brazil – Remote

⏳ Contract/Temporary

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Visanco - Consultoria em Assuntos Regulatórios na Área de Vigilância Sanitária

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 1997

🍽️ Food & Beverage

📦 Logistics

⚖️ Legal

Food & Beverage • Logistics • Legal

Visanco is a specialized Technical Consultancy Company established in 1997, based in Brasília, Brazil. It provides services focused on Regulatory Affairs in the health sector, assisting businesses in navigating the complex landscape of health surveillance and inspection. The company supports over 600 clients, including national and international firms, with a wide range of services such as quality control systems, regulatory compliance, and product registration. Visanco's team comprises qualified professionals from various fields, including nutrition, pharmacy, and health management, ensuring comprehensive support in adhering to health regulations and standards.

📋 Description

• Serve as a Senior GMP / Quality Assurance Analyst in the pharmaceutical industry • Advise companies and laboratories on regulatory affairs and health surveillance requirements • Plan and conduct national and international audits of manufacturers • Prepare audit reports, classify nonconformities, and monitor CAPA plans • Prepare for and support health authority inspections and certification processes with Anvisa • Prepare, review, and monitor Operating Authorization (AFE) and Special Authorization (AE) processes • Conduct and review process, cleaning, and analytical method validations • Conduct and review the qualification of equipment, systems, and utilities • Critically evaluate technical documents related to quality control, development, and production • Provide support for pharmaceutical technology transfers • Deliver in-company training in Brazil and abroad on GMP, Quality Assurance and Quality Control, Risk Analysis, Qualification, and Validation • Serve and participate in meetings with domestic and international clients, including in English

🎯 Requirements

• Academic background: Pharmacy • Solid experience in Good Manufacturing Practices (GMP), Quality Assurance, and the regulatory approval of companies subject to Anvisa health surveillance oversight • Knowledge of applicable health regulations and GMP requirements • Knowledge of Quality Management Systems and procedures related to Quality Assurance • Experience with national and international GMP audits, including planning, execution, report preparation, and action plans • Experience preparing for and supporting health authority inspections and certification processes with Anvisa • Experience assessing the regulatory compliance of companies, manufacturing processes, and quality systems • Experience preparing and evaluating technical documentation, standard operating procedures, and quality records • Experience analyzing protocols and reports for analytical methods, processes, cleaning, and systems • Experience identifying nonconformities, conducting root-cause analyses, and monitoring corrective and preventive actions • Experience preparing and delivering general and specialized Good Practices training • Experience preparing, submitting, and monitoring applications for and renewals of the Good Manufacturing Practices Certification (CBPF) • Excellent command of formal written and spoken Portuguese • Excellent Portuguese and English reading comprehension and text interpretation skills • Advanced English proficiency, including fluent reading, writing, listening, and speaking • Availability to travel domestically and internationally • Proficiency with the Windows operating system, Microsoft Office (Word, Excel, PowerPoint, and Outlook), and Anvisa systems • Postgraduate education in Good Manufacturing Practices, Quality Assurance, Regulatory Affairs, Health Surveillance, the Pharmaceutical Industry, or international regulations is desirable

🏖️ Benefits

• Education and professional development assistance • Health assistance • Remote work and flexible hours • Flexible policy for scheduled absences • Working-hours compensation system • Year-end break and Carnival Wednesday break

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume