- Stockholm, Sweden
- Quality Assurance (QA)
Currently I am looking for a QA Specialist for a medical device company near Stockholm, Sweden.
* To support the implementation of the Corporate Quality Manual and the applicable ISO 9001 & ISO 13485 standards and directives at the Nordic level
* To support in application of the processes and development of procedures related to mentioned activities
* To support the responsible person and/or qualified person in areas related to QA and compliance to and with National regulations (EU GDP, HSLF-FS 2016:17 (LVFS 2014 :8) )
* To support the implementation of Quality System related to distribution and technical services, where applicable
* To ensure, that processes and procedures related to mentioned activities are in compliance to local regulations, to the Corporate Quality Manual and to the ISO 9000 and 13485 requirements,
ESSENTIAL DUTIES AND RESPONSIBILITIES
Quality Responsible on site:
- Act on behalf of the RP (Responsible Person) for quality matters (by delegate)
- Returned goods management review and release returns on behalf of the RP
- Support warehouse and distribution in day to day quality matters
- Manage local QA aspects of samples and samples labelling
ERP (JDE/Wisslog) expert user (QA modules and systems):
- Quality expert in distribution related aspects
- Update & maintain selling authorization/sell restriction for each country.
- Part Master maintenance/selling authorisation
- Batch recall reporting
- Hold - JDE/Swisslog local administrator
- Prepare processes and procedures to support JDE/Swisslog system users
- For all distribution requirements in the area of responsibility and after verification that they comply with all applicable requirements in cooperation with manufacturing plants and warehouse-to-warehouse moves, and/or on status requirements.
- Manage temp tale control of cold and freeze shipments and review temperature ranges for all applicable shipments.
- Apply for and coordinate national releases of biologics derived products.
- Ensure tracking and follow-up are in place for local non-conformity reports.
- Support in audits and inspections (internal/external) as needed
- Act as back up for the Nordic CQA team (ex SQA, FCA, Complaints)
- The position requires an individual with a degree in pharmacy or science to eligible to act as RP as
per HSLF-FS 2016:17 [LVFS2014:8] (EU GDP)
- Fluent in Swedish and English
- At least 5 years in Quality Assurance.
- GMP/GDP background
Are you the new QA Specialist? Apply online or to speak to a consultant about this project, contact Niek van Alfen via +31 (0)20 522 1588 or n.vanalfen[at]realstaffing.com