Quality Assurance Specialist Latam

Vifor Pharma; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global pharmaceutical company in Brazil is seeking a Quality Assurance Specialist to expand their Quality Management System and ensure compliance with GxP standards. The role involves managing product complaints, ensuring training, and supporting inspections. The ideal candidate should have a relevant degree, 3 to 5 years of industry experience, and be fluent in English and Portuguese. This is a great opportunity to contribute to healthcare quality initiatives in the LATAM region.

Qualificações

• 3 to 5 years of pharmaceutical industry experience is required.
• Understanding of GxP principles and standards is essential.
• Experience in GMP and/or GDP will be a plus.

Responsabilidades

• Expand the Quality Management System.
• Manage product complaints, issues, and deviations.
• Ensure training on QMS and maintenance of LMS system.
• Support during Health authorities' inspections.

Conhecimentos

GxP systems knowledge

Risk management

Excellent communication skills

Good Documentation Practices

Fluent in English and Portuguese

Formação académica

Health, life sciences, medical science or engineering degree

Ferramentas

Word

PowerPoint

Excel

Descrição da oferta de emprego

- CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialise in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Our affiliate in Brazil was established 2 years ago and we want to strengthen our Quality Department with a Quality Assurance Specialist. In this new position, you will be in charge of expanding our Quality Management System and supporting projects of LATAM Regional office. Your tasks will be divided 70% for Brazil affiliate and 30% for the LATAM Regional office. You will be reporting to the Regional QPPV & Regulatory Affairs Manager.

Key Tasks

• Quality management systems QMS i.e. setting and maintaining Regional/local quality manual, procedures based on global CSL Vifor processes.
• Setting contractual obligation for quality with service provider.
• Managing products complaints, issues, deviations, CAPA and recalls when occurred.
• Ensuring training of regional office and local Affiliate on the QMS and using Learning Management software LMS.
• Maintenance LMS system in the Region and local Affiliate, update and annual reviews.
• Inspection readiness program and support during Health authorities' inspection in LATAM region.
• Manage deviations and incidents; investigations in the Distribution, Supply Chain, Warehouse and global CSL manufacturing sites.
• Ensure the establishment, review, approval of compliance reports.
• Follow-up of deviations related to these records.
• Define appropriate corrective and preventive actions and monitor them.
• Change control Management, Documentation Management and Complaints Management.
• Follow up Product Quality Review reports with local Manufacturers.
• Involved in Review/approval of Transport deviation and product release with distributors.
• External and Internal Audits.
• Participate in setting Quality Objective and continuous Quality improvement projects.
• Ensure the compliance of the quality management system with CSL global objective.
• Provide GDP/GMP training to all collaborators.
• Support continuous improvement and Operational Excellence initiatives.
• Implement Risk management principles.
• Experience in writing audit reports and Temperature Mapping reviews.
• Support qualification of partners and the negotiation of Quality Agreements.

Qualifications

• A health, life sciences, medical science or engineering degree; or equivalent by experience.
• 3 to 5 years of pharmaceutical industry experience.
• Knowledge of GxP systems & requirements and/or.
• Understanding of GxP principles, concepts, practices & standards.
• Understanding of risk management.
• Availability to travel 10% of the time.
• Experience in GMP and/or GDP will be considered a plus.
• Excellent communication skills.
• Proficient in Good Documentation Practices.
• Excellent written & spoken English & Portuguese.
• Fluency in Spanish will be considered a plus.
• Excellent computer skills: Word, PowerPoint & Excel.

About Us

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialise in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.