QA CAPA & Compliant Specialist

Firmenname für PREMIUM-Mitglieder sichtbar

April 2021

November 2021

A-Austria

auf Anfrage

19.11.2020

CR/104334_1605779752

Projektbeschreibung

*** QA CAPA & COMPLIANT SPECIALIST ***



Interesting opportunity within a global pharmaceutical company based in Austria!

An innovative and growing Pharmaceutical company is looking for new Quality Assurance CAPA and Compliant Specialist for the upcoming 8 months project in 2021. As QA Specialist you contribute to Quality Assurance initiates by managing the controlled document process and ensuring compliance with applicable regulatory requirements. Your mission will be to improve treatment options in different therapeutical areas and analyse CAPA trends.



Responsibilities:

* Define and maintain the QMS that is consistent with the requirements by proactively developing and improving it
* Independent investigation of product complaints
* Write the reports and corrective and preventive action plans following the report sent by clients / authorities and ensure their dissemination
* Ensure the investigations and propose an analysis concerning the planned and unplanned GMP and CAPA deviations
* Internal and external audits
* Independent assurance of the implementation of new global and local requirements in ​​CAPA and complaints



Required Skills:

* Degree in Biotechnology, Chemistry, or other natural science
* Good knowledge of the pharmaceutical environment
* Comprehensive knowledge of Quality Management Systems
* Confident writing in SOPs & putting quality plans together
* Experience in change management, deviations and CAPA systems
* Fluent in German and English
* Strong team orientation and solution-oriented working approach

If you're passionate about this job offer, we encourage you to apply today!

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