Site Quality Control Manager, Qualified Person (w/m/d), Bonn

328982BR
Oct 04, 2021
Germany

Job Description

Job Purpose:

The Site Quality Control Manager is in charge of the maintenance at local level of the national quality management system as per GMP regulation and corporate guidelines as well as of all health regulated activities ensuring that all the relevant external and internal requirements are implemented, monitored for performance and adherence.

Major Activities:

• Raw materials, packaging materials, semi-finished products acceptance according to specifications;
• Manage, coordinate and approve the execution of the analytical activities for the batch release;
• Ensure that all quality control processes, equipment and software are validated/calibrated according to the Validation Master Plan;
• Ensure the maintenance of all quality control equipment according to the Validation Master Plan;
• Ensure that all methods used in QC analysis are validated according to SOPs, MA and cGMPs;
• Guarantee the cleanliness and tidiness and application of Good Laboratory Practice;
• Assure the adequacy of the SOPs of Quality Control department;
• Perform the audit trail review of the quality control equipment software;
• Verify the data integrity of the QC software;
• Maintain, review and approve the records of the QC activities;
• Ensure the existence of a system of procedures to guarantee the quality and efficacy of the QC department;
• Ensure that all QC materials are properly and safely stored, identified, labelled recorded and monitored according to SOPs and specifications;
• Ensure that the stock of materials, reagents, standards is properly available and ordered;
• Ensure, in collaboration with QA department, that out of specifications, out of trend, deviations, CAPA, change controls related to the QC department are addressed and recorded according to cGMP and SOPs;
• Collaborate with other functions for the redaction of the stability programs and the annual product review according to the calendar;
• Ensure the initial and periodic training of QC analysts;
• Manage the presence, shifts and performances of the QC analysist;
• Act directly to the audits performed at the site by the Country Quality Head;
• Act participate during the Health Authorities and during the subcontractor inspections;
• Participate in the corrective actions at local level the follow up of the Health Authorities and the subcontractor inspections;
• Ensure the complete independence of the QC activities from the TechOps department;
• Assure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities requirements;
• Assure the escalation to the Country Quality Head in case of critical issues.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Education:

Scientific Degree (Preferred qualification to Qualified Person)

Languages:

English fluently, verbally and in writing

Experience / Professional requirements:

 2+ years of experience in QC dept.
 Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills
 Open and clear collaboration and communication to make sure the daily operation runs smoothly
 Shows the appropriate sense of urgency around given tasks
 Reliable, present and able to transmit the energy necessary to continue an improvement process and consolidate the system
 Preferred qualification to Qualified Person
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Germany
Düsseldorf
Quality
Full Time
Regular
No
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328982BR

Site Quality Control Manager, Qualified Person (w/m/d), Bonn

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