QA (Senior) Specialist

Job Title: QA (Senior) Specialist

Location: Geneva , Switzerland

Contract Type: Temporary 3 months, possibility of extension - Full-time (100% or minimum 80%)

Start Date: ASAP

Remote Work: 1-day/week 

About the Company: 

An international pharmaceutical company headquartered in Geneva, specializing in vaccines and biologics. The company plays a strategic role in product development, manufacturing oversight, regulatory affairs, supply chain, and product lifecycle management. 

The role in a nutshell: 

• Manage QA Operations internally and with External partners

• Support QMS activities

• Ensure completeness of documentation

Your responsibilities:

Complaints:

• Process and Coordinate quality complaints according to SOP

• Track progress within timelines

• Prepare/compile complaint investigation summary

• Maintain Complaints tracker and documentation

Change controls:

• Process and Coordinate change control internal or from partners

• according to SOP

• Track and contribute to Quality actions progress within timelines

• Support preparation CC board

• Maintain Changes tracker and documentation

Deviations:

• Process and Coordinate internal or partners deviations according to

• SOP

CAPAs:

• Process and Coordinate CAPA handling according to SOP

• Track CAPA progress

• Maintain CAPAs tracker and documentation

Third parties: Coordinate QTAs progress / track audit follow up or GxP request

Support issuance or update of GxP documents for QMS

Support other Quality activities

Your profile: 

• Minimum 5 years experience with commercial QA operations for medicinal products
• Experience with Compliance/Quality Systems
• Experience working with external partners
• Fluent in French and English writing and speaking
• Good knowledge of pharmaceutical GMPs and GDPs