Quality Assurance Expert

Há 3 dias

São Paulo, São Paulo, Brasil beBeeQuality Tempo inteiro R$80.000 - R$120.000

Job Title: Quality Assurance Specialist

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Job Description:

We are seeking a rigorous Quality Assurance Specialist to strengthen our Quality Department with a strong focus on expanding our Quality Management System and supporting projects of the LATAM Regional office.

 

  • Expand our Quality Management System by setting and maintaining regional/local quality manual, procedures based on global processes.
  • Set contractual obligations for quality with service providers.
  • Manage products complaints, issues, deviations, CAPA and recalls when occurred.
  • Ensure training of regional offices and local affiliates on the QMS and using Learning Management software.
  • 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.

 

Required Skills and Qualifications:

We are looking for a candidate with 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.

 

Benefits:

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