Principal Engineer Q-Systems API Geel-00000RXS
Description
The position is critical to support the quality performance & compliance management of the Geel site across all departments. You will operate major quality processes (e.g., internal audits, deviation handling, escalation and recall, change control, etc.) and ensure high performance and inspection readiness at any time by proactive and close cooperation with all involved departments on- and off-site (Production, engineering, planning, quality, labs, regulatory etc.).
The Quality Systems principal engineer is part of the Quality systems group, and reports to the Senior Manager Q-systems.
Responsibilities:
- Manage major quality systems and influence the Geel Quality organization on continuous improvement: internal audits, deviation handling, change control, escalation and recall management, performance metrics
- Develop and maintain procedures related to the assigned processes and the execution of programs/ projects associated with these processes
- Manage quality related metrics on the site and collaborate with all applicable groups to achieve objectives
- In cooperation with applicable groups, evaluate data related to deviations and changes to proactively identify trends and areas for improvement
- Support of inspection management for HA’s and Customers
- Collaborate strongly with the Global Quality Systems group and other global groups (e.g. regulatory, PDMS, …)
Qualifications
- Scientific degree in chemistry, pharmaceuticals or related major
- 10 years working experience in GMP environment
- Background QA, QC, Quality systems, GMP production
- Passion for oversight management
- Global mindset with excellent communication skills
- Change agent and strong influencing skills
- Experience in international cooperation
- Fluent in Dutch and English
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
STEP-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Geel
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality (Eng)
Description
The position is critical to support the quality performance & compliance management of the Geel site across all departments. You will operate major quality processes (e.g., internal audits, deviation handling, escalation and recall, change control, etc.) and ensure high performance and inspection readiness at any time by proactive and close cooperation with all involved departments on- and off-site (Production, engineering, planning, quality, labs, regulatory etc.).
The Quality Systems principal engineer is part of the Quality systems group, and reports to the Senior Manager Q-systems.
Responsibilities:
- Manage major quality systems and influence the Geel Quality organization on continuous improvement: internal audits, deviation handling, change control, escalation and recall management, performance metrics
- Develop and maintain procedures related to the assigned processes and the execution of programs/ projects associated with these processes
- Manage quality related metrics on the site and collaborate with all applicable groups to achieve objectives
- In cooperation with applicable groups, evaluate data related to deviations and changes to proactively identify trends and areas for improvement
- Support of inspection management for HA’s and Customers
- Collaborate strongly with the Global Quality Systems group and other global groups (e.g. regulatory, PDMS, …)
Qualifications
- Scientific degree in chemistry, pharmaceuticals or related major
- 10 years working experience in GMP environment
- Background QA, QC, Quality systems, GMP production
- Passion for oversight management
- Global mindset with excellent communication skills
- Change agent and strong influencing skills
- Experience in international cooperation
- Fluent in Dutch and English
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
STEP-BE
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Geel
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Quality (Eng)