Validation Manager with GxP experience (Freelance / Greater Copenhagen)

We are looking for 1-2 Validation Managers to help our client with the compliance part of IT-systems.

Tasks

  • Ensuring that the criticality of the system is evaluated and documented
  • Work closely with QA to ensure the overall quality assurance
  • Managing and driving the validation effort
  • Contributing to the project plan for the validation phase
  • Facilitate and report Risk Assessment and maintenance of the risk register during the project phase.
  • Produce the Validation Master Plan, Validation Plan and the Validation Report
  • Ensuring quality of deliverables (User Requirement Specification, Functional and Technical design Specifications)
  • Establishment and approval of IQ and OQ, PQ protocols and –reports
  • Creation of Traceability matrix (TRM)
  • Creation and/or management of requirements, test sets and test cases, defects and traceability matrix using MicroFocus ALM tool
  • Support LoB and IT in writing/review IT SOPs such as IT administration, or/and IT operation and maintenance SOPs
  • Ensuring adherence to good documentation practice in test cases writing and execution

Allocation

Start: April 2021

Duration: End of 2021

Location: 100% remote due to corona. When possible again location is onsite.

Contact

Please contact Tina Malchau on tma@twins.dk or +45 20 78 09 42.

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  • Tina Malchau, Twins

    Kontakt:

    Tina Malchau

    Rekrutteringsspecialist / Sourcing

    Mail: tma@twins.dk
    Mobil: 20 78 09 42