Du führst Routineprüfungen durch, validierst analytische Methoden und sorgst für die Instandhaltung der Laborausrüstung im Einklang mit GMP.
Anforderungen
- •Mindestens 3 Jahre Erfahrung in QC-Umgebung
- •Erfahrung in der Analyse großer Moleküle
- •Erfahrung in DP-Behältertests
- •Erfahrung mit Empower von Vorteil
- •Erfahrung mit Lean-Prinzipien wünschenswert
- •Erfahrung in Gerätequalifizierung und CSV
Deine Aufgaben
- •Routine testing durchführen (Freigabe, Stabilitätsanalyse, Methodenvalidierung)
- •Compendiale Methoden für parenterale Arzneimittel umsetzen (z. B. Osmolarität, Farbklärung, pH)
- •Analytische Methoden validieren und übertragen (z. B. HPLC, CE, Solo-VPE, CCIT)
- •Analytische Testmethoden und Validierungsberichte entwerfen und überprüfen
- •Laborausrüstung für Routineprüfungen einrichten und warten
- •Standardarbeitsanweisungen für analytische Geräte unter GMP definieren und pflegen
- •EHS-, Qualitäts- und Lean-Prinzipien im Arbeitsbereich aufrechterhalten
Deine Vorteile
Wertvolle Karriereentwicklungschance
Flexible Arbeitsbedingungen
Zusammenarbeit mit erfahrenen Mitarbeitern
Vielfältige Schulungsmöglichkeiten
Wettbewerbsfähiger Pensionsplan
Original Beschreibung
## QC Lab Professional 100% (d/f/m)
###### Permanent employee, Full-time ·Basel
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##### Your mission
**We are looking for an experienced QC Lab Professional to support our Basel team..**
Your responsibilities will include,
* Conducting routine testing (release, stability analysis and method validation) on parenteral dosage forms under GMP
* Implementation of compendial methods for parenteral drug applications (e.g. Osmolarity, Color Clarity, pH)
* Performing analytical method validation and transfer (e.g. HPLC, CE, Solo-VPE, CCIT, Break Loose / Extrusion Force Methods)
* Draft and review analytical test method descriptions, method implementation, validation, transfer plans and reports
* Set up and maintain lab equipment for routine testing
* Define and maintain standard working procedures and other quality-related documents for use of analytical equipment under GMP
* Maintain EHS, quality and lean principles throughout the workspace
##### Your profile
We are looking for someone:
* At least 3 years hands on experience in release, stability testing and method validation in a QC environment
* Experience in analysis of large molecules and drug products, e.g. CE, HPLC, compendial methods
* Experience in DP filled container testing e.g. Dye Ingress, He-Leak, break loose glide force
* Experience with Empower desirable
* Experience with lean principles, e.g. 5S and KanBan is a plus
* Experience in equipment qualification and CSV highly appreciated
##### Why us?
We offer:
* A valuable and impactful career development opportunity in a inspiring environment
* Flexible working arrangements and environment with an open culture and diverse workforce
* The opportunity to work with and learn from highly qualified and experienced employees
* Our learning and self-developing culture offers a wide range of training options
* Competitive pension fund plan, annual bonus, and other financial and non-financial benefit
At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.
##### About us
While most applicants fall short of 100% qualifications, we embrace diverse perspectives and encourage applications from all qualified candidates, regardless of background. Women & underrepresented groups, we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.