Quality Assurance- Complaints Specialist

Há 24 horas

Santo Amaro, Brasil Novartis Tempo inteiro
**Summary**:
Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
**About the Role**:
**About the role**:
- 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
- Responsible for complaint management, including entry, follow-ups, product analysis, and closure.
- Develop and establish reports for prompt review of new complaints, regulatory reporting decisions, and follow-up.
- Code events and ensure all required information for a complaint file is obtained and properly documented.
- Evaluate all information from a clinical and technical perspective to ensure appropriate analysis, investigation, root cause, and quality engineering review.
- Track, receive, and ship products as needed.
- Execute daily complaints analysis and failure investigations, documenting results and relevant information.
- Approve complaints in assigned product families.
- Set up complaint meetings and effectively communicate with worldwide complaint groups and internal departments.
**Minimum Requirements**:
- Functional Breadth
- 3 y of experience in complaints and investigations.
- 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.
Division
Operations
Business Unit
Innovative Medicines
Location
Brazil
Site
Santo Amaro
Company / Legal Entity
BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A
Alternative Location 1
INSURGENTES, Mexico
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No

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