PROLYTIC

PROLYTIC ist ein wissenschaftlich-technisches Dienstleistungsunternehmen, das sich an biotechnologische und pharmazeutische Unternehmen richtet. Wir bieten ein breites Spektrum an analytischen Dienstleistungen in den Bereichen Bioanalytik, Pharmakokinetik, Pharmazeutische Analytik und RNA/DNA-Analytik, von der präklinischen und klinischen Entwicklung bis zur Vermarktung von verschiedenen Arzneistoffen an.

Stellenbeschreibung

Prolytic GmbH | Part of the Kymos Group

About Prolytic / Kymos Group

Prolytic GmbH is a specialized GLP-certified bioanalytical laboratory and has been part of the Kymos Group since 2020. The Kymos Group is a leading international CRO providing analytical and bioanalytical services to support drug development from preclinical stages to market authorization.

To strengthen our Quality Assurance team, we are looking for a motivated QA Specialist (m/f/d) to join us at the earliest possible date.

Your Responsibilities

Maintenance and continuous improvement of the GLP quality system
QA review and approval of study plans, raw data, and final study reports
Handling of deviations, OOS/OOT investigations, and follow-up of CAPAs
Preparation, review, and maintenance of SOPs and quality-relevant documentation
Planning, conduct, and follow-up of internal audits and of customer and regulatory inspections
Training of staff in GLP and QA-related topics
Close collaboration with bioanalytical departments and the QA teams within the Kymos Group

We Offer

A responsible and varied position in an established GLP-certified bioanalytical laboratory
Integration into an international CRO group with development and career opportunities
Opportunity to work on innovative drug development programs for international biotech and pharma clients
Flat hierarchies and short decision-making processes
A collaborative and scientifically driven working environment
Flexible Working hours / flextime
Good accessibility by car and public transportation
Free drinks (coffee, tea, water)
Company medical care
Competitive salary and benefits package

Interested?
We look forward to receiving your application and getting to know you.

Anforderungen

Your Profile

University degree in a life science discipline (e.g. Biology, Chemistry, Biochemistry) or a comparable qualification
Professional experience in Quality Assurance within GLP and sound knowledge of GLP regulations
Knowledge of GMP-regulations desirable
Structured, detail-oriented, and independent working style
Strong communication skills and a collaborative mindset
Very good command of German and English

Kymos

Jobs:

QA Specialist

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