Quality Assurance Analyst

Novartis

  • Brasil
  • Permanente
  • Período integral
  • Há 7 dias
Job Description Summary -Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.Job DescriptionMajor accountabilities:
  • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
  • On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration
Minimum Requirements:
Work Experience:
  • Functional Breadth.
  • QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
  • Collaborating across boundaries.
  • cleanliness zones.
Skills:
  • Continuous Learning.
  • Dealing With Ambiguity.
  • Gmp Procedures.
  • Qa (Quality Assurance).
  • Quality Control (Qc) Testing.
  • Quality Standards.
  • Self Awareness.
  • Technological Expertise.
  • Technological Intelligence.
Languages :
  • English.
Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Novartis