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QA Audit Manager

vor 4 Monaten

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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.

Quality Assurance Audit Manager - Sr. Quality Assurance Specialist

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

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 complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.