CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize 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.
- 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
For this interesting role, we are looking for a rigorous person bringing the following profile:
- 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 as a plus
- Excellent communication skills
- Proficient in Good Documentation Practices
- Excellent written & spoken English & Portuguese
- Fluency in Spanish will be considered as a plus
- Excellent computer skills: Word, PowerPoint & Excel