Senior QA Specialist

Posted 08 September 2021
Job type Limited
DisciplineQuality Assurance/Safety

Job description

For our client, an international company in the field of pharmaceutical products and medical devices, we are looking for a Senior QA Specialist for their distribution center for Medical Devices.

Senior QA Specialist - 100%

Contract type: external temporary assignment
Location: Selzach (Kanton Solothurn)
Start of assignment: 1st October 2021
Duration: planned until 31st January 2022

Job responsibilities

Quality systems compliance overview

* Assure compliance oversight to make sure QMS is working properly
* Assess regional/global documents being updated and decide if the local procedures need to be adopted
* Initiate execution of updates with the SME

Internal audit and inspection management

* Process ownership and continuous improvement
* Planning, execution and follow up for internal audits in Distribution Center, hosting of internal audits for QA processes

Purchasing control

* Process ownership and continuous improvement
* Local purchasing control in collaboration with another site
* Support in the field of Service Level Agreements (incl. GxP assessment of the suppliers and respective communication with team of another site)

QEM approval

* Oversight on the Quality Event Management
* Decision with the process owner in case of doubts
* Take ownership and support Operations with Quality Issues for the warehouse zones this role is assigned to

QEM support

* Act as Quality Leader for owned QA processes
* Support QEM SME in case of workload increase
* Act as compliance support for Operations partners for all Quality Issues in the owned warehouse zones

Repack & relabelling support

* Support batch record verification for repack and relabelling activities

Your profile

* Bachelor's degree in a scientific discipline

* At least 5 years of related experience in areas such as Quality Operations, Compliance, Supplier Quality or Quality Systems

* Strong interpersonal, communication and influencing skills

* Strong collaboration skills, the ability to communicate written and verbally in a virtual global environment and to work effectively with cross-functional teams

* Fluency in English and German

Please apply online.
We are looking forward to getting to know you.