Quality Assurance Analyst III | Palhoça-SC

The Quality Assurance Analyst III is responsible for ensuring regulatory compliance and adherence to Good Distribution and Fractionation Practices of pharmaceutical ingredients. They act strategically in supplier qualification, technical documentation review, management of complaints, deviations, and risks, ensuring that products meet ANVISA standards (RDC 204/2006 and related) and corporate standards.

Responsibilities and assignments

Decision on Use of Pharmaceutical Ingredients: Release of ingredients for commercialization, verifying traceability, good documentation practices, and data integrity; Technical Documentation Management: Review and approve standard operating procedures (SOPs), work instructions, analysis reports, technical data sheets, among others; Risk and Change Management: Conduct risk analyses (FMEA/HACCP) for import/distribution processes and manage Change Control; Deviations and CAPA: Investigate quality deviations, non-conformities, customer complaints, and manage Corrective and Preventive Actions (CAPA); Audits: Act as a lead auditor or member in internal audits and audits of suppliers/third-party logistics (3PL); Training: Provide training in the quality assurance area; Equipment and Utilities Management: Manage calibration deadlines and equipment qualification, approve Calibration Certificates and qualification documentation.

Requirements and qualifications

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Additional information

Completed degree in Pharmacy; Need to assume Technical Responsibility (active CRF); Approximately 5 years of experience in quality management systems in pharmaceutical industries or importers/distributors of pharmaceutical ingredients; Deep knowledge of ANVISA RDCs applicable to pharmaceutical ingredients (fractionation, distribution, storage, and transport) and good manufacturing practices; Advanced English (will deal with meetings and documents in English). Desirable: knowledge in ERP SAP and SESuite systems; Postgraduate degree in the Quality Assurance area or related area.