Quality Assurance- Complaints Specialist

Há 7 dias

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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