Quality Documentation and QMS Specialist Uppsala ID:108
What you’ll do:
Provide support to the project team and Quality organization specific to eQMS, data migration from SmartSolve to Veeva
Data Sampling based on statistical justification and Verifications of the migrated data (data is migrated automatically)
Assist in collating data for user access requirements from various sites and coordinate with IT in the provision of system access
You will be able to learn two electronic Documentation management system and two electronic QMS (Smart Solve and Veeva)
In partnership with Quality on custumer site you will support NC-CAPA, audit and complaint records timely closure in preparation for manual data transfer
Act as a QA reviewer and approver on QMS records where appropriate
Coordinate the team of QA SME on 10 sites in the process of records closure and manual transfer of records from the old to new systems over period of 8 weeks.
Work on preparation for the archiving of the old system, writing URS and agree on the configuration requirements
Leading and supporting QA projects and continuous improvement activities as required. Coordinate with the key stakeholders and multi-disciplinary teams on key projects
Who you are:
Bachelor's degree, preferably in a Science or Engineering discipline or equivalent working experience in Lifescience, Medical devices or Pharma industry.
A minimum of 5 years working in Quality Assurance
Comprehensive understanding of ISO and GMP QMS requirements
Hands-on experience with validation is an advantage
Exceptional analytical, problem solving & root-cause analysis skills.
Excellent communication skills (written and oral)
Experienced in working cross – functionally and at global level is essential
Ability to handle tasks with competing priorities effectively, exercising collaboration, negotiation & conflict resolution skills
Working knowledge on eQMS or eDMS platforms is desired.
Other of importance:
The position is based in Uppsala
Hybrid remote/onsite (2-3 days office).