Quality Assurance Manager

3 days ago


Copenhagen, Copenhagen, Denmark PQE Group Full time
Job Description

PQE Group, a leading consulting services provider in the Pharmaceutical and Medical Device sectors, is seeking a Quality Assurance Manager to support one of our clients in Copenhagen. The successful candidate will lead QC laboratory digitalization and automation projects, ensuring the successful implementation of LIMS, CDS, and other lab informatics solutions.

Responsibilities:
  • Manage end-to-end validation of computerized systems, including preparation of Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports, following GAMP 5 guidelines and CFR 21 Part 11 compliance.
  • Oversee the integration of laboratory systems (LIMS, CDS, ELN) with enterprise platforms, ensuring seamless data flow and compliance with Data Integrity principles.
  • Drive process improvements in QC operations using Lean Six Sigma methodologies, identifying opportunities for automation and workflow optimization.
  • Coordinate and collaborate with internal and external stakeholders, including IT, QA, QC, suppliers, and regulatory bodies, to ensure successful execution of automation projects.
  • Support Change Control and CAPA processes related to laboratory digitalization and automation.


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