Senior GMP Analyst – Quality Assurance

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Act as a Senior GMP / Quality Assurance Analyst within the pharmaceutical sector

• Provide guidance to companies and laboratories regarding regulatory affairs and health surveillance standards

• Organize and execute national and international audits of manufacturers

• Draft audit reports, categorize nonconformities, and oversee CAPA plans

• Prepare for and facilitate health authority inspections and certification procedures with Anvisa

• Prepare, assess, and oversee Operating Authorization (AFE) and Special Authorization (AE) processes

• Conduct and evaluate process, cleaning, and analytical method validations

• Execute and review the qualification of equipment, systems, and utilities

• Thoroughly assess technical documents pertaining to quality control, development, and production

• Offer support for pharmaceutical technology transfers

• Provide in-company training in Brazil and internationally on GMP, Quality Assurance and Quality Control, Risk Analysis, Qualification, and Validation

• Participate in meetings with both domestic and international clients, including in English

⛳️ Requirements

• Educational background: Pharmacy

• Extensive experience in Good Manufacturing Practices (GMP), Quality Assurance, and the regulatory approval processes for companies under Anvisa health surveillance

• Familiarity with relevant health regulations and GMP standards

• Understanding of Quality Management Systems and related Quality Assurance procedures

• Proven experience with national and international GMP audits, encompassing planning, execution, report generation, and action planning

• Experience in preparing for and facilitating health authority inspections and certification processes with Anvisa

• Expertise in evaluating the regulatory compliance of companies, manufacturing processes, and quality systems

• Skilled in preparing and reviewing technical documentation, standard operating procedures, and quality records

• Experience in analyzing protocols and reports regarding analytical methods, processes, cleaning, and systems

• Ability to identify nonconformities, perform root-cause analyses, and track corrective and preventive actions

• Experience in developing and delivering general and specialized Good Practices training

• Knowledge in preparing, submitting, and tracking applications for and renewals of the Good Manufacturing Practices Certification (CBPF)

• Strong command of formal written and spoken Portuguese

• Excellent reading comprehension and text interpretation abilities in both Portuguese and English

• Advanced proficiency in English, including fluent reading, writing, listening, and speaking skills

• Willingness to travel both domestically and internationally

• Proficient in the Windows operating system, Microsoft Office (Word, Excel, PowerPoint, and Outlook), and Anvisa systems

• Postgraduate qualifications in Good Manufacturing Practices, Quality Assurance, Regulatory Affairs, Health Surveillance, the Pharmaceutical Industry, or international regulations are preferred

🏝️ Benefits

• Support for education and professional development

• Health assistance

• Options for remote work and flexible working hours

• Flexible policy for scheduled absences

• Compensation system for working hours

• Year-end break and Carnival Wednesday break