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).