QA Officer Operations

BandLevel 3

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 Description

Major Accountabilities:

QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & cleanliness zones, Functional Breadth, Collaborating across boundaries

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 & communicated beforehand

Successfully support continuous improvement projects<LI>Executes batch release in compliance with registration

Work Experience:

Quality Assurance

Quality Control

Quality Management Systems

Technological Expertise

Environmental Monitoring

Release Management

Good Manufacturing Practices (cGMP)

Audit & Inspection Management

Quality Compliance

Technological Expertise

Skills:

Collaboration

Dealing With Ambiguity

Operational Excellence

Regulatory requirements knowledge

Problem Solving Skills

Leadership

Communication skills

Data Integrity

Digital saviness

Languages:

English.

Skills DesiredCollaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge

REQ-10073737