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Quality Assurance Specialist

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Italy

Offer summary

Qualifications:

Experience in QC/QA in pharmaceuticals/biotech, Knowledge of GMP procedures and standards, Strong technological expertise and intelligence, Fluent in English.

Key responsabilities:

Manage quality aspects and projects
Ensure compliance with GxP and Novartis systems
Prepare documentation for batch release
Support exception investigations and OpEx projects
Report technical complaints within 24 hours

Novartis Healthtech: Health + Technology XLarge https://www.novartis.com/

10001 Employees

See more Novartis offers

Job description

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. Prepare Documentation for Batch Release of commercial Pharmaceuticals

Job Description

Major 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