QA Audit Manager
vor 4 Wochen
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**About the role**:
This role provides a unique opportunity to be part of a growing pivotal initiative to reshape and build out the clinical supply chain for CTD in a way that allows us to leverage information for our clients and our internal partners to enhance our growth potential and customer service. The position holder is responsible for client-facing activities within the Quality Assurance department including participation in client audits. The position holder will also participate in various compliance-related activities within Fisher Clinical Services.
**Discover Impactful Work**:
- Applies expert knowledge of GMP regulations to improve and integrate across value streams (manufacturing, packaging, distribution, labeling, and comparator)
- Demonstrates pharmaceutical Quality expertise to recommend solutions to both internal and external clients to ensure compliance across the supply chain
- Maintains, develops and builds strategic client relationships
- Key Duties & Responsibilities
- Managing and hosting client audits
- Coordination of CAPAs in response to client audit findings
- Follow-up of CAPAs in order to ensure prompt resolution and closure
- Participation in Internal Audits as Auditor/Support Team, supporting the organization, execution, writing of audit report, opening and closure of audit records in the TrackWise event management system
- Initiation and implementation of measures to prevent quality deviations and reduce risk
- Data collection and analysis of Key Performance Indicators for site Quality goals
- Handling of complaints / deviations to ensure appropriate CAPAs to avoid recurrence
- Participation in Gembas, Kaizen, Practical Process Improvement projects
- Participation in Risk Assessments
- Participation in interdepartmental working groups and global project teams
- Acting as local client QA Lead for various clients including participation in routine teleconferences, Quality review meetings, and maintenance of client-specific metrics
**Education & Background**:
- 3+ years pharmaceutical GMP experience
- Excellent written and oral communication
- Excellent organizational skills
- High level of accuracy and efficiency
- Fluency in German and English preferred
- GMP knowledge
- Excellent interpersonal skills
- Ability to manage projects through implementation
**Why us?**
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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