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    QA Validation Specialist - Dublin, Ireland - Cpl

    Cpl
    Cpl Dublin, Ireland

    Found in: beBee S2 IE - 1 day ago

    CPL background
    Description

    Cpl in partnership with our client Pfizer are currently recruiting for a QA Validation Specialist for an initial 11 months contract based in their Grange Castle Site.

    To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including Automation), Technical Operations, Technical Services, Business Technology (BT) and QC.

    Responsibilities:

    General


    • Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.


    • Partner closely with customers and stake-holders to understand and deliver on all records within timelines and escalate when necessary.


    • Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies e.g. Method 1 etc. Assures completeness in terms of root cause, action taken, and CAPA.


    • Authors, tracks, review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc.


    • Support quality oversight of qualification, validation (and appropriate re-validation) activities through the review and approval of validation documents for equipment, utilities, control systems, cleaning validations and others.


    • To ensure compliance with corporate standards, internal procedures, regulatory requirements and industry standards, and stay current with all training requirements.


    • Provide support on compliance issues to Engineering, Automation, BT, Technical Operations, Technical Services and QC.


    • Provide guidance to cross-functional, multi-departmental project teams on quality regulations for Validation strategy and approach.


    • Key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement.


    • To review and approve validation protocols, procedures, specifications, reports, validation deviations and project plans as required.


    • To review Policies and Master Plans.


    • Ensure that change controls and automation change requests are compliant with applicable procedures and maintain the validated state.


    • Support the timely release of equipment, utilities, facilities and computer systems following validation activities.


    • Support and participate in site self-inspections, internal audits, board of health audits and third party audits.


    • Actively support Biotech Communities of Practice (COP) and Common Interest Groups (CIGs) as required.


    • Provide support to the Operational Units (OpU's), site projects and participate in cross-functional teams as required.

    Education/Experience Requirements:


    • B.Sc. or Eng degree in a technical based subject.


    • 2-3 years working experience in a pharmaceutical environment.


    • Excellent communication and interpersonal skills.


    • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

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