QA Consultant: Complaint Management, GMP, German

QA Consultant: Complaint management, GMP, German

I have a fantastic opportunity to further your expertise within the field of QA complaint handling inside a large and fast paced work environment.

Please find a brief description of the role below with a full description available on receipt of a relevant and up to date CV.

Job description:

The QA specialist would have following two objectives:

1. Perform complaint handling in the global complaint system (main responsibility):
a. Be able to understand the customer complaint handling process within the AH department after training (receipt of complaint, investigation of complaint, notification of customer after investigation and closing of the complaint in system).
b. Screen complaint system every day for new complaints out of countries, take minor complaints them up and forward the information to the responsible manufacturing site. Note the date of the notification in the system.
c. Notify Third Party Managers of any major or critical complaint.
d. Maintain the notification date (system available) and remind investigators to return complaint in due time
e. Receive investigation reports from manufacturers. Be able to judge for minor complaints that the investigation was performed adequately.
f. Place investigation reports in system (minor in own account). Give investigation reports for major and critical complaints to Third Party Managers for review.
g. Remember country QA to close investigated complaints in system.

Ideal Background:
*Experience in quality operations the GMP environment
*Ideally experience in customer complaint handling
*Ideally experience in the negotiation QA contracts
*Ideally experience in QA systems that support Third Party management
*Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering
*Excellent command of English, fluent in German; other languages appreciated

QA Consultant: Complaint management, GMP, German