Business Purpose
Mepha Schweiz is currently looking for a Senior Quality Assurance Manager to support the Commercial Quality Team.
In this role you will ensure GMP&GDP compliance by improving and maintaining the processes and documents of the quality management system and contribute to audits and inspections. You will perform the release of products of Mepha’s portfolio to the Swiss market and manage quality incidents, new product launches, complaints, deviations, and change control procedures. You will act as Deputy of the Responsible Person (RP) and represent the Commercial Quality Unit Team in cross functional projects.
Main Responsibilities
Perform Swiss market releases in delegation of the RP, including deviation and change control management
Act as Deputy RP (Stv. FvP)
Lead the management of quality incidents, complaints and recalls
Manage major product launches
Review PQRs
Manage Quality Technical Agreements
Create and maintain Standard Operating Procedures and Working Instructions, and contribute to the continuous improvement of processes and to trainings
Contribute to authority inspection readiness, support local authorities’ inspections, and perform internal audits
Represent Swiss QA in Teva’s European Commercial Quality organization
Lead or participate in internal project teams or working groups
Collaborate with local functions, e.g. Regulatory Affairs, Pharmacovigilance, Supply Chain, Customer Services as well as internal and external suppliers
