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    QA Validation

    DundalkContractCompetitive
    Back to job search
    2 hours ago
    JN -112026-2011392
    New

    QA Validation

    Dundalk Contract Competitive

    QA Validation

    About the job

    QA Validation Records Specialist - 9 Month Contract with potential extension- Fully Onsite

    This role will support a strategic project focused on the reconciliation, digitisation, and management of archived validation documentation, including implementation of a new archival system and electronic True Copy process.

    Bring energy, knowledge, innovation to carry out the following:

    · Review, reconcile, organise, and digitise archived validation documentation.

    · Support implementation of a new document archival system for retrospective and prospective records.

    · Facilitate conversion of paper records to compliant Electronic True Copy records.

    · Assess validation document completeness, criticality, and retention requirements.

    · Support archive reorganisation activities in partnership with CQV, Validation, and Document Control.

    · Ensure compliance with GMP, GDP, data integrity, and site document management procedures.

    · Support compliance reporting and quality system objectives related to documentation management.

    What skills you will need:

    · BSc in Science, Engineering, Quality, or related discipline (or equivalent relevant experience).

    · Experience within a pharmaceutical or other regulated quality environment.

    · Knowledge of GMP, GDP, and data integrity requirements.

    · Understanding of validation lifecycle documentation and CQV processes.

    · Strong document management, organisational, and communication skills.

    · Experience with document archival, digitisation, or electronic document management systems is desirable.

    · Able to multi-task in fast-paced, dynamic working environment.

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