Analista de Control de Calidad – Industria Farmacéutica
Eurofarma · Fraijanes
Job description
About the role
Eurofarma is seeking a Quality Control Analyst to ensure that all pharmaceutical products meet the highest standards of quality, regulatory compliance, and Good Manufacturing Practices. The analyst will manage analytical processes, review technical documentation, and support continuous improvement within the QC laboratory.
Key responsibilities
- Review and approve technical documentation and analytical results generated by the QC laboratory.
- Maintain and update specifications and analytical methods for raw materials, packaging, and finished products in line with pharmacopeias and regulations.
- Create and manage inspection plans in SAP for raw materials, primary and secondary packaging, and finished goods.
- Develop, revise, and control quality system documents such as SOPs, formats, logs, schedules, and diagrams.
- Lead investigations of out‑of‑specification results (OOS), deviations, CAPA, and change controls, ensuring procedural compliance.
- Prepare and update training and qualification documentation for QC personnel.
- Monitor environmental control records (temperature, humidity) to verify compliance.
- Approve physicochemical results of stability studies.
- Compile and present monthly regulatory reports related to precursor control.
Required profile
- Bachelor’s degree in Pharmaceutical Chemistry.
- Active professional registration (collegiate).
- Proven experience in Quality Control within the pharmaceutical industry.
- Strong knowledge of GMP, technical documentation, OOS investigations, deviations, CAPA, and change control.
- Familiarity with applicable pharmaceutical regulatory standards.
- Analytical mindset, attention to detail, and results‑oriented approach.
Required skills
- SAP (desirable).
- Good Manufacturing Practices (GMP/BPM).
- OOS investigation procedures.
- CAPA management.
- Change control processes.
- Regulatory compliance knowledge.
What we offer
- Experience in a leading multinational pharmaceutical company.
- Collaborative, innovative environment focused on excellence.
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Published 1 month ago
Expires 3 weeks from now
35 views · 0 interested
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Eurofarma
Fraijanes