You ensure compliance with GMP and QMS standards while managing customer complaints and driving improvements in quality processes. Your role includes consulting on regulatory issues and conducting thorough investigations and reviews.
Anforderungen
- •Grade as pharmacist or comparable studies
- •Experience in pharmaceutical industry
- •Thorough understanding of GMP requirements
- •Advanced verbal and written communication skills
- •Service-oriented and problem-solving mindset
- •Very good stakeholder management skills
- •Excellent analytical and organizational skills
- •Fluent in oral and written German and English
Deine Aufgaben
- •Ensure GMP and QMS compliance in GxP areas.
- •Manage customer complaints and deviations.
- •Harmonize and improve Quality Management System processes.
- •Provide consultancy on GMP compliance with regulations.
- •Conduct GEMBA Walks and coaching for production.
- •Assess investigations and CAPA, performing root cause analysis.
- •Review GMP-relevant documentation and participate in self-inspections.
Deine Vorteile
Bilingual daycare centre
Supplementary health insurance
30 holidays plus bridging days
(E-) Bike leasing and charging
Original Beschreibung
# Quality Manager (m/f/d) - limited to 2 years
Country:
Germany
City:
Aachen
Department:
Global Operations & Production
Job ID:
44555
Professional | Temporary | Full-time | On-Site
Our people in **Manufacturing & Global Operations** share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.
**What the job looks like**
Each day you'll enjoy a variety of challenges, such as:
* Ensuring GMP and QMS compliance in GxP areas
* Management of customer complaints and deviations
* Harmonization, maintenance and continual improvement of the Quality Management System processes and drive the excellence journey
* Consultancy regarding GMP issues to comply with national and international requirements regarding all pharmaceutical activities according §2 BApO (Bundes-Apothekerordnung) and AMG, AMWHV, 2001/83/EC, 2003/94/EC, 2001/20/EC, etc.
* Performance of GEMBA Walk and Coaching as well as point of contact for production
* Assessment of investigation and CAPA as well as performance of deep dive root cause analysis in cross-functional team
* QA review of GMP-relevant documentation (qualification, validation) and performance/participation of self-inspection
**What you'll bring to the table**
To make the most of this role and truly thrive, you should have:
* Grade as pharmacist or in comparable scientific studies
* Experience in pharmaceutical industry in GMP-regulated areas
* Thorough understanding of GMP requirements
* Advanced verbal and written communication skills and focused mindset, as well as team player
* Service-and problem solving oriented and enjoy working in interdisciplinary teams
* Very good stalkeholder management and high level of technical knowledge
* Excellent analytical and organizational skills
* Fluent in oral and written German and English
**What are some of the local benefits**
* Bilingual daycare centre “Karlinis“ and holiday activities for employees’ children
* Supplementary company health insurance
* 30 holidays, plus 6-8 bridging days and possibility to convert salary into up to 5 additional holidays
* (E-) Bike leasing and e-charging stations
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| | Fauziya Tarannum Syed, the Hiring Manager |