• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • QC Laboratory Validation Specialist – Co. Dublin

    Role Summary:

     

    • Our client, a globally renowned pharmaceutical company based in County Dublin have a fantastic opportunity for an experienced QC Laboratory Validation Specialist.
    • Working within a dynamic team, the successful candidate will be responsible for the qualification of new instrumentation, modernisation of instrumentation, and facility modification or expansion projects within the QC Laboratories.
    • This is an 11 month contract role with strong possibility for extension.

     

    Core Duties and Responsibilities:

     

    • Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle including:
      • New instrument and equipment validation (URS, IQ, OQ, PQ, Traceability Matrices, Summary Reports
      • Periodic review of instrument qualification packages as required
      • Routine QC support with respect to instrument issues
      • Instrument and equipment validation scheduling
      • Administration of Laboratory Computerized Systems.
    • Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
    • Preparation and review of required validation documentation including protocols and reports.
    • Ensure data integrity requirements are included and met as part of the new instrument qualification.
    • Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).
    • Generation of area and System Administration SOPs.
    • Authoring, review and approval of qualification/validation protocols and reports, status reports, regulatory documents and process descriptions.
    • Completion of Security reviews, periodic reviews, compendial reviews and APQR sections as they relate to maintaining the qualified status of the system
    • Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required, in QTS.
    • Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.
    • Partner closely with customers and stakeholders to understand QC instrument and equipment validation requirements and escalate when necessary.
    • Proactive engagement with customers and key stakeholders.
    • Maintain the QC laboratories in a state of audit readiness at all times.
    • Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.
    • Participate in and drive the continuous improvement of all aspects of the group.
    • Ensure compliance with cGMP, corporate standards / Site Quality System, site policies / procedures, and regulatory requirements.
    • Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.

     

    Minimum Qualifications and Experience:

     

    • Relevant Third level Qualification or equivalent (B.Sc. degree in science, engineering, quality, technical or other related life sciences or engineering discipline.
    • 2+ years relevant experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.
    • A strong knowledge and experience of validation or qualification experience with laboratory instrumentation, validation and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.
    • Excellent communication and interpersonal skills.
    • You will be service orientated, delivery focused and can build rapport with key stakeholders both internal and external.
    • Proven experience in updating documentation and reports.
    • Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
    • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

     

    To Apply:

     

    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    GC North Valley Business Centre, Cork, T23 KC67, Ireland.

    +353 21 2066178
    recruitment@prochem.ie

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.